Trial Outcomes & Findings for Baseline Oral Health Study: UnCoVer the Connections to General Health (NCT NCT04954313)
NCT ID: NCT04954313
Last Updated: 2026-02-12
Results Overview
The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health.
COMPLETED
PHASE4
786 participants
Comparing T1 (day 90) and T4 (day 360)
2026-02-12
Participant Flow
Of the 786 participants who signed informed consent, 194 completed the required assessments, and remained eligible. Of the 194 eligible participants, 39 declined to be randomized. Of the 155 randomized participants, two did not continue following randomization and did not receive any exposure to a study intervention.
Participant milestones
| Measure |
Control Group
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
Periodontal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
|
Treatment Group
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
Subgingival chlorhexidine irrigation: The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).
Dental Supplies: Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.
Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
82
|
|
Overall Study
Completed T0 (Day 0)
|
73
|
80
|
|
Overall Study
Completed T1 (Day 90)
|
65
|
70
|
|
Overall Study
Completed T2 (Day 180)
|
61
|
65
|
|
Overall Study
Completed T3 (Day 270)
|
56
|
57
|
|
Overall Study
Completed T4 (Day 360)
|
54
|
56
|
|
Overall Study
COMPLETED
|
53
|
54
|
|
Overall Study
NOT COMPLETED
|
20
|
28
|
Reasons for withdrawal
| Measure |
Control Group
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
Periodontal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
|
Treatment Group
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
Subgingival chlorhexidine irrigation: The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).
Dental Supplies: Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.
Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
12
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
11
|
13
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
Baseline characteristics by cohort
| Measure |
Control Group
n=73 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
|
Treatment Group
n=80 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
Subgingival chlorhexidine irrigation: The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).
Dental Supplies: Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.
Periodonal Treatment: Initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planing (SRP).
|
Total
n=153 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
66 Participants
n=41 Participants
|
72 Participants
n=1581 Participants
|
138 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
15 Participants
n=4626 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=41 Participants
|
47 Participants
n=1581 Participants
|
89 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=41 Participants
|
33 Participants
n=1581 Participants
|
64 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
3 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=41 Participants
|
1 Participants
n=1581 Participants
|
2 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
36 Participants
n=41 Participants
|
41 Participants
n=1581 Participants
|
77 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=41 Participants
|
33 Participants
n=1581 Participants
|
63 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
5 Participants
n=1581 Participants
|
8 Participants
n=4626 Participants
|
|
Diabetes/pre-diabetes
Prediabetes/diabetes ( HbA1c >=5.7 at screening)
|
57 Participants
n=41 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
64 Participants
n=1581 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
121 Participants
n=4626 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
|
Diabetes/pre-diabetes
Non-prediabetes/non-diabetes ( HbA1c < 5.7 at screening)
|
16 Participants
n=41 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
14 Participants
n=1581 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
30 Participants
n=4626 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
|
Diabetes/pre-diabetes
Uncategorized (HbA1c not recorded at screening or T0)
|
0 Participants
n=41 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
2 Participants
n=1581 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
2 Participants
n=4626 Participants • HbA1c was measured at screening for classification. For one participant, HbA1c at screening was not recorded and classification was based on HbA1c measured at T0 (day 0). For two participants, HbA1c was not recorded at screening not recorded at T0, and no prediabetes/diabetes classification was made.
|
PRIMARY outcome
Timeframe: Comparing T1 (day 90) and T4 (day 360)Population: Data include imputation. Predictions based on linear mixed models were used for imputation.
The impact of treatment on oral health measures, will be performed using generalized estimating equations (GEE) methods. Longitudinal outcomes in the Treated vs. Control groups will be compared and will include all subjects who were randomized and their data from visits T1 - T4 based on intent-to-treat (ITT) group assignment. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health.
Outcome measures
| Measure |
Control Group
n=73 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=80 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Impact of Treatment on Change in Oral Health Measures
|
0.186 millimeters (probing depth difference)
Interval 0.0863 to 0.285
|
0.190 millimeters (probing depth difference)
Interval 0.0737 to 0.306
|
PRIMARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants meeting the following criteria: (1) HbA1c data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points, and (3) screening HbA1c \>= 5.7 (if screening value was not available, T0 value of HbA1c \>= 5.7 was used as proxy).
The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and % change in HbA1c will be determined in subjects with prediabetes or type 2 diabetes at screening.
Outcome measures
| Measure |
Control Group
n=38 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=46 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Association Between Changes in Oral Health (Probing Depth) and Changes in Systemic Health (HbA1c)
|
-0.093 Pearson correlation coefficient
0.379
|
-0.282 Pearson correlation coefficient
0.5123
|
PRIMARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants meeting the following criteria: (1) flow mediated dilation data was available at T0 and T4 time points, (2) probing depth data was available at T0 and T4 time points.
The association between changes in oral health and changes in systemic health, will be evaluated using correlation analysis. Periodontal probing depths (mm) will be measured per sextant. Whole-mouth mean probing depths will be used as a measure of oral health. The correlation between % change in whole-mouth mean probing depth and change in flow-mediated dilation will be calculated.
Outcome measures
| Measure |
Control Group
n=46 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=49 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Association Between Changes in Oral Health and Changes in Systemic Health (Flow-mediated Dilation)
|
-0.0528 Pearson correlation coefficient
0.3635
|
0.006 Pearson correlation coefficient
0.5227
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants who completed the survey at T0 and T4 time points.
Emotional wellbeing will be evaluated through the use of PANAS (Positive Affect and Negative Affect Scales). PANAS consists of 10 positive and 10 negative valence word items. Items are rated by the participant to indicate their assessment of how they are feeling about this item "right now" on a scale of 1(slightly) or not at all through 5 (extremely). 10 of of the items form a positive affect subscale, in which a higher score indicates increased positive affect, with a subscale range of 10 to 50. 10 of the items form a negative affect subscale, in which a higher score indicates more negative affect, with a subscale range of 10 to 50. This outcome measure is change in the 10 item positive affect subscale.
Outcome measures
| Measure |
Control Group
n=16 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=15 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Change in Emotional Wellbeing
|
1.25 scores on a scale
Standard Deviation 6.93
|
-0.6 scores on a scale
Standard Deviation 7.09
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants who completed the survey at T0 and T4 time points.
Beliefs about periodontal disease will be evaluated through the use of a Protective Motivation Theory (PMT) survey. PMT surveys assess an individual's motivation to adopt protective health behaviors by focusing on specific cognitive processes. This survey includes 7 statements related to opinions on periodontal disease and treatment (e.g., "Periodontal disease worries me," "Adhering to my periodontal treatment instructions over the next weeks will improve my oral health"). Each survey item is scored from 1 to 10 with 1 being "not at all" to 10 being "extremely so." Higher values indicate stronger agreement with the survey statements. Reported outcome measures represent total survey scores (range from 7 to 70).
Outcome measures
| Measure |
Control Group
n=16 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=15 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Change in Beliefs About Periodontal Disease
|
2.56 scores on a scale
Standard Deviation 8.75
|
-0.60 scores on a scale
Standard Deviation 4.47
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants who received dental assessment at T0 and T4 time points.
Whole-mouth mean of tooth-specific dichotomic response (bleeding = 1, no bleeding = 0) after probing the gingival sulcus.
Outcome measures
| Measure |
Control Group
n=54 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=56 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Change in Bleeding on Probing
|
-0.109 scores on a scale
Standard Deviation 0.188
|
-0.212 scores on a scale
Standard Deviation 0.236
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants who received dental assessment at T0 and T4 time points.
The gingival index will be scored on three facial surfaces (distofacial, facial, mesiofacial) and three lingual surfaces (distolingual, lingual, mesiolingual). Areas are examined by placing the periodontal probe under the gingival margin at approximately 1mm deep and sweeping the probe from the distal surface to the mesial surface in quadrants I and IV and mesial to the distal surface in quadrants II and III. After each quadrant is swept, calls are made based on gingival inflammation and the presence or absence of bleeding according to criteria which range from 0 to 3. Loe and Silness Gingival Index (GI); scale: 0 = normal gingiva, 1 = mild inflammation, 2 = moderate inflammation, 3 = severe inflammation. For this Outcome Measure, less inflammation (lower number) correlates with better outcome. Reported outcome measure is whole-mouth mean value (six surfaces of each tooth), with a range of 0 to 3.
Outcome measures
| Measure |
Control Group
n=54 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=56 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Change in Gingival Index
|
-0.154 scores on a scale
Standard Deviation 0.47
|
-0.379 scores on a scale
Standard Deviation 0.559
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants who received dental assessment at T0 and T4 time points.
Percent change of whole-mouth mean clinical attachment level (CAL, defined as measured pocket depth - gingival margin, for each site). Percent change calculated as (CAL@T4 - CAL@T0)/CAL@T0.
Outcome measures
| Measure |
Control Group
n=54 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=56 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change in Clinical Attachment Level (CAL)
|
-0.31 % change
Standard Deviation 22.2
|
0.90 % change
Standard Deviation 25.2
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants who received dental assessment at T0 and T4 time points.
Change of digitally measured interdental plaque area. Full mouth plaque assessment shall be assessed using the UNC Modified Plaque Index (Greene and Vermillion). Plaque scores shall be visually assessed at 6 sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual surfaces) on a scale of 0-3. Scores are the following: 0 =No debris or stain present on the clinical crown; 1 =Soft debris covering not more than 1/3 of the clinical crown (cervical 3rd), or presence of extrinsic stains without other debris regardless of surface area covered; 2 =Soft debris covering more than 1/3, but not more than 2/3 (middle 3rd) of the clinical crown; 3 =Soft debris covering more than 2/3 of the clinical crown. Reported outcome measure is calculated as whole-mouth mean (mean of each site at each tooth) with a range of 0 to 3.
Outcome measures
| Measure |
Control Group
n=54 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=55 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Change in Dental Plaque Index
|
-0.090 scores on a scale
Standard Deviation 0.579
|
-0.181 scores on a scale
Standard Deviation 0.537
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Some participants did not have FMD measured at T0 and/or T4 and are not included in the T4-T0 comparison. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality.
Change of flow mediated dilation. Ultrasound images of the right brachial artery and Doppler measures of arterial flow will be acquired before and after reactive hyperemia is induced by inflating a pneumatic occlusion cuff placed around the lower arm. FMD will be calculated as the percent change in arterial diameter from baseline.
Outcome measures
| Measure |
Control Group
n=46 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=49 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Change in Flow-mediated Dilation
|
-0.488 % change
Standard Deviation 4.97
|
0.45 % change
Standard Deviation 4.23
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants meeting the following criteria: (1) biomarker data was available at T0 and T4 time points and (2) screening HbA1c \>= 5.7 (if screening value was not available, T0 value of HbA1c \>= 5.7 was used as proxy).
Percent change of HbA1c (% glycated) from day 0 to day 360 \[(HbA1c@T4 - HbA1c@T0) / HbA1c@T0\] in the prediabetic and diabetic cohorts (HbA1c \>= 5.7 at screening)
Outcome measures
| Measure |
Control Group
n=38 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=46 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change in Glycated Hemoglobin (HbA1c) (Prediabetic and Type 2 Diabetic Cohorts)
|
-0.99 % change
Standard Deviation 2.21
|
-0.65 % change
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Some participants are missing measurement data at either T0 or T4 timepoints, precluding calculation of T0 to T4 percent change. Missing data arises from a combination of participant withdrawal/loss to followup and poor ultrasound data quality.
Percent change of IMT. Longitudinal ultrasound images of the distal 1 cm segments of the right and left common carotid arteries, carotid bulbs, and internal carotid arteries will be acquired. IMT will be measured as the distance between luminal-intimal interface and medial-adventitial interface. Mean IMT will be calculated as the average of all measurements; mean maximum IMT will be calculated as the average of maximum wall thicknesses for each of the regions. Percent change of IMT (mm) from day 0 to day 360 is calculated as (IMT@T4 - IMT@T0) / IMT@T0\]
Outcome measures
| Measure |
Control Group
n=46 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=44 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change in Carotid Intima Media Thickness (IMT)
|
2.76 % change
Standard Deviation 14.9
|
3.48 % change
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.
Percent change of hs-CRP (mg/dL) from day 0 to day 360 \[(CRP@T4 - CRP@T0) / CRP@T0\]
Outcome measures
| Measure |
Control Group
n=51 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=52 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change of High Sensitivity C-reactive Protein (Hs-CRP)
|
-8.56 % change
Standard Deviation 70.4
|
21.8 % change
Standard Deviation 171
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.
Percent change of total cholesterol (mg/dL) from day 0 to day 360 \[(tchol@T4 - tchol@T0) / tchol@T0\]
Outcome measures
| Measure |
Control Group
n=50 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=52 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change in Total Cholesterol
|
-0.0554 % change
Standard Deviation 18.0
|
-0.710 % change
Standard Deviation 16.2
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.
Percent change of low density lipoproteins (LDL) cholesterol (mg/dL) from day 0 to day 360 \[(LDL@T4 - LDL@T0) / LDL@T0\]
Outcome measures
| Measure |
Control Group
n=50 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=51 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change in Low Density Lipoprotein (LDL) Cholesterol
|
2.63 % change
Standard Deviation 35.1
|
-0.033 % change
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: Comparing T0 (day 0) and T4 (day 360)Population: Analysis population includes only participants for whom biomarker data was available at T0 and T4 time points.
Percent change of triglycerides (mg/dL) from day 0 to day 360 \[(trig@T4 - trig@T0) / trig@T0\]
Outcome measures
| Measure |
Control Group
n=44 Participants
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=48 Participants
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Percent Change in Triglycerides
|
-2.86 % change
Standard Deviation 19.3
|
-1.52 % change
Standard Deviation 21.9
|
Adverse Events
Control Group
Treatment Group
Serious adverse events
| Measure |
Control Group
n=73 participants at risk
The Control Group will receive an initial periodontal treatment consisting of a pre-procedural rinse and scaling \& root planning (SRP).
Subjects in the Control Group will receive no products during the course of the study. They will receive a commercial connected toothbrush, toothpaste, mouthwash, proxabrush, and floss at the end of the study. Subjects will be scheduled to receive flow mediated dilation (FMD) and carotid intima media thickness (IMT) measurements prior to Baseline and approximately 4 weeks after their Baseline visit.
|
Treatment Group
n=80 participants at risk
The Treatment Group will receive the same periodontal treatment in addition to having subgingival chlorhexidine irrigation. All subjects will also complete a set of questionnaires (PANAS \& PMT) using an online form. A subset of 50 subjects from each group will be randomly selected to have oral images captured using an intra-oral scanner at Baseline and a subset of follow-up visits. Additionally, subjects in the Treatment Group will also receive brief behavioral advice from dental professionals focusing mainly on motivation and acknowledgement.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
1.4%
1/73 • From T0 (day 0) through the end of study, up to 15 months
|
0.00%
0/80 • From T0 (day 0) through the end of study, up to 15 months
|
Other adverse events
Adverse event data not reported
Additional Information
Saroja Voruganti, PhD
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place