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

NCT05654662 | Completed Results

• 1 other identifier: 300029
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gingivitis; Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12

  The number of bleeding sites was calculated using the bleeding index (BI) assessment. The BI was assessed for all evaluable surfaces (having two-thirds of the natural tooth surface gradable for the assessment) of the facial and lingual/palatal gingiva, 6 sites per tooth (mesiobuccal, buccal, and distobuccal; mesiolingual/palatal, lingual/palatal, and distolingual/palatal). Evaluable tooth sites were probed, and gingival bleeding was assessed for approximately 30 seconds after probing. The number of bleeding sites 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 bleeding.

  Baseline and Week 12

Secondary Outcomes (11)

• Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 12 (Test Product Versus [vs.] Reference Product)

  Baseline and Week 12

• Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6

  Baseline, Week 3, and Week 6

• Adjusted Mean Change From Baseline in Number of Bleeding Sites at Week 3 and Week 6 (Test Product vs. Reference Product)

  Baseline, Week 3, and Week 6

• Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12

  Baseline, Weeks 3, 6 and 12

• Adjusted Mean Change From Baseline in Mean BI at Weeks 3, 6 and 12 (Test Product vs. Reference Product)

  Baseline, Weeks 3, 6 and 12

Study Arms (2)

Corsodyl Original Dentifrice

EXPERIMENTAL

Participants will be instructed to brush their teeth using test product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion.

Drug: Corsodyl Original Dentifrice

Colgate Cavity Protection Dentifrice

ACTIVE COMPARATOR

Participants will be instructed to brush their teeth using reference product for at least a minute twice a day (morning and evening) for 12 weeks. Participants will dose the toothbrush provided with a ribbon of paste to cover the brush head (a full brush head) on each brushing occasion.

Drug: Colgate Cavity Protection Dentifrice

Interventions

Corsodyl Original Dentifrice DRUG

It contains 67% weight/weight (w/w) Sodium Bicarbonate and 0.310% w/w Sodium Fluoride (1400 parts per million \[ppm\] Fluoride ion \[F\])

Corsodyl Original Dentifrice

Colgate Cavity Protection Dentifrice DRUG

It contains 0.76% w/w Sodium Monofluorophosphate (1000 ppm F) and 0.1% w/w Sodium Fluoride (450 ppm F)

Colgate Cavity Protection Dentifrice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 (\<) bleeding on probing (BOP) \< 30%.
• A participant with mean whole mouth TPI score more than or equal to (\>=)1.5.

You may not qualify if:

• 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 participant who has a bleeding disorder that could have affected study outcomes and/or participant safety.
• A participant who has a recent history (within the last year) of alcohol or other substance abuse.
• A participant who has a severe oral condition (such as, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.

Sponsors & Collaborators

• HALEON: lead

Study Sites (1)

University of Bristol, Bristol Dental School and Hospital

Bristol, BS1 2LY, United Kingdom

Location

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Results Point of Contact

• Title: Haleon Response Center
• Organization: HALEON

ww.clinical-trial-register@haleon.com

+441932959500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: February 20, 2023
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: January 13, 2025
• Results First Posted: January 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension can be granted, when justified, for up to another 12 months.

Locations

GB (1)