Trial Outcomes & Findings for A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks (NCT NCT06143670)
NCT ID: NCT06143670
Last Updated: 2025-03-21
Results Overview
The NBS were calculated using the bleeding index (BI) assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
COMPLETED
NA
159 participants
Baseline and Week 12
2025-03-21
Participant Flow
This study was conducted at a single center in the United States.
A total of 162 participants were screened of which 159 participants were enrolled, and 152 participants were randomized to receive treatment in 2 groups: Test Product group (76 participants) and Reference Product group (76 participants). 10 participants were not randomized (7 participants did not meet the study criteria, 2 participants withdrew consent, and 1 participant had an adverse event \[AE\]). A total of 148 randomized participants completed the study.
Participant milestones
| Measure |
Test Product
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2) across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
76
|
|
Overall Study
COMPLETED
|
73
|
75
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Test Product
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454 percent (%) weight by weight (w/w) stannous fluoride (SnF2) across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
A Clinical Study Investigating the Effects of a Dentifrice Containing 0.454% Stannous Fluoride on Gingivitis Treatment and Plaque Reduction When Used Twice Daily for 12 Weeks
Baseline characteristics by cohort
| Measure |
Test Product
n=76 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.8 years
STANDARD_DEVIATION 14.00 • n=99 Participants
|
50.5 years
STANDARD_DEVIATION 13.04 • n=107 Participants
|
49.2 years
STANDARD_DEVIATION 13.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
73 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
8 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
64 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
129 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Modified Intent-To-Treat (mITT) population included all randomized participants who completed at least one use of study product and had at least one post baseline clinical performance assessment.
The NBS were calculated using the bleeding index (BI) assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 millimeter (mm) and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in the Number of Bleeding Sites (NBS) at Week 12
|
-14.6 bleeding sites
Standard Error 0.99
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 12Population: mITT population. Here, overall number analyzed is defined as the number of participants with data available for analysis of this outcome measure.
The NBS were calculated using the BI assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at Week 12. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=75 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in the NBS at Week 12 (Test Product Versus [vs.] Reference Product)
|
-14.6 bleeding sites
Standard Error 0.99
|
2.2 bleeding sites
Standard Error 0.98
|
SECONDARY outcome
Timeframe: Baseline, Week 3 and Week 6Population: mITT population. Only those participants available at the indicated timepoints were analyzed.
The NBS were calculated using the BI assessment. BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. The BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. The probe was gently inserted into the gingival crevice to a depth of approximately 1 mm and then run around the tooth gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. NBS for each participant was calculated as the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline was defined as Day 0. A negative change from Baseline indicated improvement in gingival condition.
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product)
Change from Baseline at Week 3
|
-14.8 bleeding sites
Standard Error 1.05
|
1.2 bleeding sites
Standard Error 1.01
|
|
Adjusted Mean Change From Baseline in the NBS at Week 3 and Week 6 (Test Product vs. Reference Product)
Change from Baseline at Week 6
|
-16.7 bleeding sites
Standard Error 0.84
|
0.9 bleeding sites
Standard Error 0.82
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6 and 12Population: mITT population. Only those participants available at the indicated timepoints were analyzed.
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution, disclosed plaque was then scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Overall TPI score for each participant=Sum of index values over all evaluable tooth sites (sites scored as 0 to 5), divided by the number of evaluable tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 3
|
-0.30 score on a scale
Standard Error 0.026
|
-0.02 score on a scale
Standard Error 0.025
|
|
Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 6
|
-0.29 score on a scale
Standard Error 0.023
|
-0.10 score on a scale
Standard Error 0.023
|
|
Adjusted Mean Change From Baseline in Mean Overall Turesky Plaque Index (TPI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 12
|
-0.32 score on a scale
Standard Error 0.025
|
-0.03 score on a scale
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6 and 12Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
TPI was used to assess plaque on the facial and lingual surfaces of each scorable tooth. The plaque was first disclosed using a plaque disclosing dye solution and scored on a 6-point scale ranging from 0 to 5, where 0=No plaque; 1=Separate flecks of plaque at the cervical margin; 2=Thin continuous band of plaque (up to 1 mm) at the cervical margin; 3=Band of plaque wider than 1 mm but covering less than one third of the tooth surface; 4=Plaque covering more than one third but less than two thirds of the tooth surface; 5=Plaque covering more than two thirds of the tooth surface. Interproximal TPI score for each participant=Sum of index values over all evaluable distal and mesial tooth sites, divided by the number of evaluable distal and mesial tooth sites and ranged from 0 to 5. Lower score=better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline value. Baseline=Day 0. A negative change from Baseline indicated improvement (less plaque accumulation).
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 3
|
-0.23 score on a scale
Standard Error 0.022
|
-0.02 score on a scale
Standard Error 0.021
|
|
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 6
|
-0.25 score on a scale
Standard Error 0.020
|
-0.09 score on a scale
Standard Error 0.019
|
|
Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 12
|
-0.28 score on a scale
Standard Error 0.022
|
-0.04 score on a scale
Standard Error 0.021
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6 and 12Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
BI assesses the number of bleeding points elicited on probing as a measure of gingival condition. BI was assessed on the facial and lingual gingival surfaces of each scorable tooth using PCP11.5B Hu-Friedy Qulix Color Coded probe. Gingival bleeding was scored on a 3-points scale with scores ranging from 0 to 2, where 0=No bleeding after 30 seconds, 1=Bleeding observed within 30 seconds of probing, 2=Bleeding observed immediately on probing. BI score for each participant=sum of index values over all evaluable tooth sites (those scored as 0, 1, or 2), divided by the number of evaluable tooth sites. Lower score=better outcome. Change from Baseline was calculated by subtracting the Baseline value from the value at each indicated timepoint. Baseline=Day 0. A negative change from Baseline indicated improvement in gingival condition.
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 3
|
-0.12 score on a scale
Standard Error 0.009
|
0.01 score on a scale
Standard Error 0.009
|
|
Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 6
|
-0.14 score on a scale
Standard Error 0.007
|
0.01 score on a scale
Standard Error 0.007
|
|
Adjusted Mean Change From Baseline in BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 12
|
-0.12 score on a scale
Standard Error 0.009
|
0.01 score on a scale
Standard Error 0.009
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 6 and 12Population: mITT Population. Only those participants available at the indicated timepoints were analyzed.
MGI assessment is a non-invasive evaluation which focuses on visual symptoms of gingivitis (example, redness, texture, edema). MGI was assessed on facial and lingual surfaces of each scorable tooth and scored on a 5-point scale ranging from 0 to 4, where 0=Absence of inflammation; 1=Mild inflammation; slight change in color, little change in color; little change in texture of any portion of marginal or papillary gingival unit; 2=Mild inflammation; criteria as 1 but involving entire marginal or papillary gingival unit; 3=Moderate inflammation; glazing, redness, edema, and/or hypertrophy of marginal or papillary gingival unit; 4=Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Lower score indicated better outcome. Change from Baseline=Value at each indicated timepoint minus Baseline \[Day 0\] value. A negative change from Baseline indicated improvement in symptoms.
Outcome measures
| Measure |
Test Product
n=73 Participants
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 Participants
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 3
|
-0.51 score on a scale
Standard Error 0.037
|
0.12 score on a scale
Standard Error 0.036
|
|
Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 6
|
-0.71 score on a scale
Standard Error 0.032
|
-0.07 score on a scale
Standard Error 0.032
|
|
Adjusted Mean Change From Baseline in Modified Gingival Index (MGI) at Weeks 3, 6 and 12 (Test Product vs. Reference Product)
Change from Baseline at Week 12
|
-0.71 score on a scale
Standard Error 0.034
|
-0.03 score on a scale
Standard Error 0.034
|
Adverse Events
Test Product
Reference Product (Negative Control)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Product
n=76 participants at risk
Participants were instructed to apply a ribbon of test toothpaste (Parodontax Complete Protection) containing 0.454% w/w SnF2 across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
Reference Product (Negative Control)
n=76 participants at risk
Participants were instructed to apply a ribbon of reference toothpaste (Crest Cavity Protection) containing 0.243% w/w sodium fluoride across the full brush head of toothbrush provided and brush their teeth for at least one (timed) minute twice daily (morning and evening) for 12 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
5.3%
4/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
2.6%
2/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
APHTHOUS ULCER
|
1.3%
1/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
2.6%
2/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Gastrointestinal disorders
HYPERAESTHESIA TEETH
|
0.00%
0/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
1.3%
1/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
1.3%
1/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
0.00%
0/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
1.3%
1/76 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 111 days).
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study product including any washout or lead-in product (or medical device), whether or not considered related to the study product, including any washout or lead-in product (or medical device). A Serious Adverse Event (SAE) was a particular category of an AE where the adverse outcome is serious.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee HALEON agreements may vary with individual investigators but will not prohibit any investigator from publishing. HALEON supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER