Phase 4
N=130
A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 Weeks
Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT04050722 ↗Enrolled (actual)
130
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Whole Mouth Mean Bleeding Index (BI) at Week 3 — 0.14; 0.20 score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sensodyne Repair and Protect (Drug); Colgate Cavity Protection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Mouth Mean Bleeding Index (BI) at Week 3 |
0.14; 0.20 | <0.0001 sig |
| SECONDARY Whole Mouth Mean Bleeding Index (BI) at Week 2 |
0.15; 0.22 | — |
| SECONDARY Mean Number of Bleeding Sites (NBS) at Week 2 and Week 3 |
21.0; 31.7; 19.7; 28.0 | — |
| SECONDARY Mean Modified Gingival Index (MGI) at Week 2 and Week 3 |
2.08; 2.18; 2.05; 2.15 | — |
| SECONDARY Mean Overall Turesky Modification of the Quigley & Hein Plaque Index (TPI) Score at Week 2 and Week 3 |
2.35; 2.81; 2.33; 2.76 | — |
| SECONDARY Mean Interproximal Turesky Modification of the Quigley & Hein Plaque Index (TPI) at Week 2 and Week 3 |
2.48; 2.90; 2.47; 2.88 | — |
Summary
The aim of this study is to investigate the impact of a stannous fluoride containing toothpaste in reducing gingivitis when used twice daily for a maximum for 3 weeks, when compared to a standard sodium fluoride toothpaste (negative control).
Eligibility Criteria
Inclusion Criteria
An individual must meet all the following inclusion criteria to be eligible for enrollment into the study:
- 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.
- A 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 or 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.
- A participant at screening (Visit 1) with: a)at least 20 natural permanent teeth excluding 3rd molars; b)at least 40 evaluable surfaces (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); or c) participants with generalized mild-moderate plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by visual examinations.
- A participant at baseline (prior to dental prophylaxis, (Visit 2) with: a)ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces; b) mean whole mouth Modified Gingival Index (MGI) greater than equal to (>=) 1.75 to less than equal to (<=) 2.30; c) mean whole mouth supra-gingival Turesky Plaque Index (TPI) score ≥ 1.5; d) ≥ 20 bleeding sites.
Exclusion Criteria
An individual who meets any of the following exclusion criteria will not be eligible for enrollment into the study:
- 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 GlaxoSmithKline 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 with, in the opinion of the investigator or medically qualified designee, any clinically significant/relevant abnormalities in medical history or oral examination, or any other condition, that would affect the individual's ability to understand and follow study procedures and requirements.
- A participant with any medical condition which, in the opinion of the investigator or medically qualified designee, is causing xerostomia.
- A participant with any medical condition which in the opinion of the investigator or medically qualified designee, could directly influence gingival bleeding.
- A participant who is pregnant or intending to become pregnant over the duration of the study (self-reported).
- A participant who is breastfeeding.
- A participant w
Data sourced from ClinicalTrials.gov (NCT04050722). 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.