Trial Outcomes & Findings for A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis (NCT NCT04737538)
NCT ID: NCT04737538
Last Updated: 2024-01-19
Results Overview
Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 millimeter (mm) and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using Analysis of Covariance (ANCOVA) model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (experimental dentifrice vs negative control dentifrice).
COMPLETED
PHASE2
110 participants
At Week 6
2024-01-19
Participant Flow
The study was conducted at single center in Canada.
A total of 110 participants were enrolled into the study and allocated to a randomized treatment. Of these 36 participants were randomized to the experimental dentifrice group and positive control dentifrice group each and 38 participants were randomized to the negative control dentifrice group. All the randomized participants completed the study.
Participant milestones
| Measure |
Experimental Dentifrice
Participants were instructed to apply full ribbon of toothpaste (containing 67 percent \[%\] weight/weight \[w/w\] sodium bicarbonate, 0.2% w/w sodium hyaluronate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Positive Control Dentifrice
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Negative Control Dentifrice
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 0.221% w/w fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
38
|
|
Overall Study
COMPLETED
|
36
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis
Baseline characteristics by cohort
| Measure |
Experimental Dentifrice
n=36 Participants
Participants were instructed to apply full ribbon of toothpaste (containing 67% w/w sodium bicarbonate, 0.2% w/w sodium hyaluronate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Positive Control Dentifrice
n=36 Participants
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 0.221% w/w fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.9 Years
STANDARD_DEVIATION 14.49 • n=5 Participants
|
41.5 Years
STANDARD_DEVIATION 16.52 • n=7 Participants
|
40.3 Years
STANDARD_DEVIATION 13.41 • n=5 Participants
|
39.9 Years
STANDARD_DEVIATION 14.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - Central/South Asian Heritage
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - South-East Asian Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
68 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Week 6Population: Modified Intent-to-Treat (mITT) Population: Comprised of all randomized participants who received at least one dose of the study product and provided at least one post-baseline assessment of efficacy.
Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 millimeter (mm) and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using Analysis of Covariance (ANCOVA) model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (experimental dentifrice vs negative control dentifrice).
Outcome measures
| Measure |
Experimental Dentifrice
n=36 Participants
Participants were instructed to apply full ribbon of toothpaste (containing 67% w/w sodium bicarbonate, 0.2% w/w sodium hyaluronate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 0.221% w/w fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
|---|---|---|
|
Number of Bleeding Sites at 6 Weeks (Comparison of Experimental Versus Negative Control Dentifrice)
|
9.5 Number of Sites
Standard Error 0.80
|
20.5 Number of Sites
Standard Error 0.78
|
SECONDARY outcome
Timeframe: At Week 6Population: mITT Population
Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 mm and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using ANCOVA model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (experimental dentifrice vs positive control dentifrice).
Outcome measures
| Measure |
Experimental Dentifrice
n=36 Participants
Participants were instructed to apply full ribbon of toothpaste (containing 67% w/w sodium bicarbonate, 0.2% w/w sodium hyaluronate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Negative Control Dentifrice
n=36 Participants
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 0.221% w/w fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
|---|---|---|
|
Number of Bleeding Sites at Week 6 (Comparison of Experimental Versus Positive Control Dentifrice)
|
9.8 Number of Sites
Standard Error 0.71
|
9.4 Number of Sites
Standard Error 0.71
|
SECONDARY outcome
Timeframe: At Week 6Population: mITT Population
Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 mm and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using ANCOVA model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (positive control dentifrice vs negative control dentifrice).
Outcome measures
| Measure |
Experimental Dentifrice
n=36 Participants
Participants were instructed to apply full ribbon of toothpaste (containing 67% w/w sodium bicarbonate, 0.2% w/w sodium hyaluronate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
Negative Control Dentifrice
n=38 Participants
Participants were instructed to apply full ribbon of toothpaste (dentifrice containing 0.221% w/w fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and to brush their teeth for one timed minute twice a day (morning and evening) for 6 weeks.
|
|---|---|---|
|
Number of Bleeding Sites at Week 6 (Comparison of Positive Versus Negative Control Dentifrice)
|
9.1 Number of Sites
Standard Error 0.85
|
20.6 Number of Sites
Standard Error 0.82
|
Adverse Events
Experimental Dentifrice
Positive Control Dentifrice
Negative Control Dentifrice
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK 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