Trial Outcomes & Findings for A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health (NCT NCT06602466)
NCT ID: NCT06602466
Last Updated: 2026-01-22
Results Overview
The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
175 participants
Primary outcome timeframe
Week 4
Results posted on
2026-01-22
Participant Flow
This study was conducted at a single center in United Kingdom.
A total 175 participants were enrolled; 161 participants were randomized to a treatment (80 participants in the test product group and 81 participants in the reference product group). Total 154 participants completed the study (76 participants in the test product group and 78 participants in the reference product group).
Participant milestones
| Measure |
Test Toothpaste
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454 percent \[%\] Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
81
|
|
Overall Study
COMPLETED
|
76
|
78
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Test Toothpaste
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454 percent \[%\] Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
Baseline characteristics by cohort
| Measure |
Test Toothpaste
n=78 Participants
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=83 Participants
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Total
n=161 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.0 years
STANDARD_DEVIATION 11.75 • n=270 Participants
|
27.9 years
STANDARD_DEVIATION 11.76 • n=4 Participants
|
27.5 years
STANDARD_DEVIATION 11.73 • n=9 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=270 Participants
|
44 Participants
n=4 Participants
|
88 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=270 Participants
|
39 Participants
n=4 Participants
|
73 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=270 Participants
|
83 Participants
n=4 Participants
|
161 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
5 Participants
n=270 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
26 Participants
n=270 Participants
|
29 Participants
n=4 Participants
|
55 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
4 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
6 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
3 Participants
n=270 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
29 Participants
n=270 Participants
|
28 Participants
n=4 Participants
|
57 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
5 Participants
n=270 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Week 4Population: Modified Intent-To-Treat (mITT) Population comprised of all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline BI assessment.
The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Outcome measures
| Measure |
Test Toothpaste
n=76 Participants
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=78 Participants
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Adjusted Mean Bleeding Index (BI) at Week 4
|
0.19 score on a scale
Standard Error 0.013
|
0.21 score on a scale
Standard Error 0.013
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population.
The bleeding assessment was done using round-end probe. The number of bleeding sites for each participant= the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Adjusted mean value was derived using ANCOVA model.
Outcome measures
| Measure |
Test Toothpaste
n=76 Participants
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=78 Participants
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Adjusted Mean Number of Bleeding Sites (NBS) at Week 4
|
30.0 bleeding sites
Standard Error 1.96
|
32.5 bleeding sites
Standard Error 1.93
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population.
The MGI is a non-invasive visual assessment of gingival inflammation. MGI was assessed for all evaluable surfaces, four sites per tooth and was scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 4= Severe inflammation. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Outcome measures
| Measure |
Test Toothpaste
n=76 Participants
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=78 Participants
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Adjusted Mean Modified Gingival Index (MGI) at Week 4
|
1.79 score on a scale
Standard Error 0.011
|
1.83 score on a scale
Standard Error 0.010
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population.
The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Outcome measures
| Measure |
Test Toothpaste
n=76 Participants
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=78 Participants
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4
|
2.64 score on a scale
Standard Error 0.037
|
2.62 score on a scale
Standard Error 0.036
|
SECONDARY outcome
Timeframe: Week 4Population: mITT Population.
The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Outcome measures
| Measure |
Test Toothpaste
n=76 Participants
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=78 Participants
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Adjusted Mean Interproximal TPI at Week 4
|
3.03 score on a scale
Standard Error 0.039
|
3.03 score on a scale
Standard Error 0.038
|
Adverse Events
Test Toothpaste
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Reference Toothpaste (Negative Control)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Toothpaste
n=78 participants at risk
Participants were instructed to brush their teeth with full ribbon of test toothpaste (containing 0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
Reference Toothpaste (Negative Control)
n=83 participants at risk
Participants were instructed to brush their teeth with full ribbon of reference toothpaste (Colgate Cavity Protection) on head of toothbrush for one timed minute twice a day (morning and evening) for 4 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
ORAL MUCOSAL EXFOLIATION
|
5.1%
4/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
2.4%
2/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
HYPERAESTHESIA TEETH
|
2.6%
2/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
1.2%
1/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
ORAL DISCOMFORT
|
2.6%
2/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
TONGUE ULCERATION
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
1.2%
1/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
GINGIVAL PAIN
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
PARAESTHESIA ORAL
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
STOMATITIS
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Gastrointestinal disorders
SWOLLEN TONGUE
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
0.00%
0/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
1.2%
1/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
1.2%
1/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
|
Nervous system disorders
MIGRAINE
|
1.3%
1/78 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
0.00%
0/83 • From signing of informed consent form until 5 days after last administration of study product or last study procedure (up to approximately 69 days).
Post randomization, two participants (from test group) received incorrect study product (i.e. Reference product). The Safety Population is presented using actual study product received and thus, the Overall Number of Baseline Participants in "Reference Toothpaste (Negative Control)" is greater than the number of participants included in the Participant Flow module.
|
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