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

NCT ID: NCT05654662

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 197 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2023-11-30

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.

Detailed Description

This will be a single center, controlled, single blind (examiner blind), randomized, two treatment arm, parallel study in volunteers with clinically measurable levels of gingivitis (defined as those with 10-30% bleeding sites on probing). Approximately 200 participants (100 per group) will be randomized to ensure 188 evaluable participants (94 per group) complete the study.

Conditions

Gingivitis; Dental Plaque

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Corsodyl Original Dentifrice

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.

Group Type: EXPERIMENTAL

Corsodyl Original Dentifrice

Intervention Type: DRUG

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

Colgate Cavity Protection Dentifrice

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.

Group Type: ACTIVE_COMPARATOR

Colgate Cavity Protection Dentifrice

Intervention Type: DRUG

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

Interventions

Corsodyl Original Dentifrice

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

Intervention Type: DRUG

Colgate Cavity Protection Dentifrice

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

Intervention Type: DRUG

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):

1. Participant with at least 20 natural, permanent teeth.

2. 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).

3. 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):

1. A participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.

2. A participant with 10% less than (<) bleeding on probing (BOP) < 30%.

3. A participant with mean whole mouth TPI score more than or equal to (>=)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 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.
• Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.

Medication Exclusions At Screening (Visit 1):

1. A participant using any antibiotic medication within 14 days prior to screening or at any time during the study.

2. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition.

3. A participant currently taking a systemic medication (such as, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (such as, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).

Medication Exclusions at Baseline (visit 2):

1. A participant who has taken (in the previous 14 days), any antibiotics.

2. A participant who has taken (in the previous 14 days) a systemic medication (such as, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (such as, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers).

3. A participant who has used an antibacterial dentifrice or mouthwash (such as, chlorhexidine) or any oral care product that in the view of the investigator could interfere with plaque formation or measures of gingivitis, in the period between Screening and the Baseline visit.

Periodontal Exclusions

1. A participant who shows signs of periodontitis (one or more sites with probing pocket depths more than [>] 3 mm).

2. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening.

3. A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice.

Dental Exclusions

1. A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.

2. A participant who has dentures (partial or full).

3. A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers).

4. A participant who received orthodontic therapy within 3 months of Screening.

5. A participant who has numerous restorations in a poor state of repair.

6. A participant who has any dental condition (such as, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.

7. A participant who has had dental prophylaxis within 12 weeks of Screening.

8. A participant who has had teeth bleaching within 12 weeks of Screening.

9. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments.

10. A participant who has previously been enrolled in this study.

11. A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HALEON

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Bristol, Bristol Dental School and Hospital

Bristol, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

300029

Identifier Type: -

Identifier Source: org_study_id