N/A
Completed N=190
A Clinical Study Investigating the Effects of a Dentifrice Containing 67% Sodium Bicarbonate When Used Twice Daily for 12 Weeks on Gingivitis Treatment and Plaque Removal
Source: ClinicalTrials.gov NCT05654662 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 — -4.3 bleeding sites — p=0.0032
Summary
The main goal of this study is to evaluate and compare the efficacy of an on-market dentifrice containing 67 percent (%) sodium bicarbonate and 0.31% sodium fluoride to a reference regular fluoride dentifrice on treating gingival bleeding and gingival inflammation as well as reducing plaque accumulation in population with gingivitis after 12 weeks use.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 |
-4.3 | 0.0032 sig |
| SECONDARY Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product) |
-4.3; 2.3 | 0.0013 sig |
| SECONDARY Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 |
-2.4; -2.4 | 0.0181 sig |
| SECONDARY Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product) |
-2.4; 1.4; -2.4; 2.9 | 0.0091 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 |
-0.04; -0.04; -0.06 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.04; -0.01; -0.04; -0.00; -0.06; -0.01 | 0.0051 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Mean Modified Gingival Index (MGI) at Weeks 3, 6 and 12 |
-0.12; -0.19; -0.24 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean MGI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.12; -0.04; -0.19; -0.06; -0.24; -0.10 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Overall TPI (Turesky Plaque Index) at Weeks 3, 6 and 12 |
-0.32; -0.31; -0.41 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Overall TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.32; -0.17; -0.31; -0.14; -0.41; -0.12 | 0.0012 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 |
-0.35; -0.34; -0.42 | <0.0001 sig |
| SECONDARY Adjusted Mean Change From Baseline in Mean Interproximal TPI at Weeks 3, 6 and 12 (Test Product vs. Reference Product) |
-0.35; -0.19; -0.34; -0.17; -0.42; -0.12 | 0.0022 sig |
Eligibility Criteria
Inclusion Criteria
- Participant provision of a signed and dated informed consent document indicating that the Participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participant who is willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- A Participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant/relevant abnormalities in medical history or upon oral examination, or condition, that would impact the Participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements.
- Participant oral health that meets all the following:
At Screening (Visit 1):
- Participant with at least 20 natural, permanent teeth.
- Participant with at least 40 evaluable surfaces for MGI, BI, and TPI (An evaluable surface is defined as having 2/3rds of the natural tooth surface gradable for the selected clinical indices. The following should not be included in the evaluable surface count- third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices).
- A participant with plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
At Baseline (Visit 2):
- A participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
- A participant with 10% less than ( =)1.5.
Exclusion Criteria
- A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or, a sponsor's employee directly involved in the conduct of the study or a member of their immediate family.
- A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- A participant who has any other clinical serious or unstable conditions (such as, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study out comes and/or participant safety.
- A participant who is a pregnant female (self-reported) or is intending to become pregnant over the duration of the study.
- A participant who is a breastfeeding female.
- A participant who is known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- A participant who is unwilling or unable to comply with the lifestyle considerations.
- Participant who is a current smoker or an ex-smoker who stopped within 6 months of Screening.
- Participant who is using smokeless forms of tobacco (such as, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
- A participant who is diagnosed xerostomia or is taking any medication that in the view of the investigator is causing xerostomia.
- A participant who has a medical condition which could have directly influenced gingival bleeding.
- A particip
Data sourced from ClinicalTrials.gov (NCT05654662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.