A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis

NCT04737538 | Completed Phase 2 Results

• 1 other identifier: 208175
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum healing. This Proof-of-Principle study will investigate the efficacy of an experimental dentifrice compared to a regular fluoride dentifrice, and also whether this provides any additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (1)

• Number of Bleeding Sites at 6 Weeks (Comparison of Experimental Versus Negative Control Dentifrice)

  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).

  At Week 6

Secondary Outcomes (2)

• Number of Bleeding Sites at Week 6 (Comparison of Experimental Versus Positive Control Dentifrice)

  At Week 6

• Number of Bleeding Sites at Week 6 (Comparison of Positive Versus Negative Control Dentifrice)

  At Week 6

Study Arms (3)

Experimental Dentifrice

EXPERIMENTAL

Participants assigned to this arm will apply full ribbon of toothpaste (containing sodium bicarbonate, sodium hyaluronate and sodium fluoride) to cover the head of toothbrush provided and will brush their teeth for one timed minute twice a day (morning and evening).

Other: Experimental Dentrifrice

Positive control

ACTIVE COMPARATOR

Participants assigned to this arm will 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 will brush their teeth for one timed minute twice a day (morning and evening).

Other: Positive control dentifrice

Negative control

ACTIVE COMPARATOR

Participants assigned to this arm will apply full ribbon of toothpaste (dentifrice containing 1100ppm fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and will brush their teeth for one timed minute twice a day (morning and evening).

Other: Negative control dentifrice

Interventions

Experimental Dentrifrice OTHER

Toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride

Experimental Dentifrice

Positive control dentifrice OTHER

Dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride

Positive control

Negative control dentifrice OTHER

Dentifrice containing 1100ppm fluoride as sodium fluoride (Crest Cavity Protection)

Negative control

Eligibility Criteria

• Age: 18 Years - 65 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.
• 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.
• Female participant of childbearing potential must have negative pregnancy test results at screening and baseline.
• Female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for 5 days after the last dose of assigned treatment. A female participant who is of childbearing potential must agree to use a highly effective method of contraception consistently and correctly for the duration of the active study period and for at least 5 days after the last dose of investigational product..
• 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.
• Participant with generalized mild- moderate plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
• At Baseline - Prior to Dental Prophylaxis (Visit 2):
• Participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
• Participant with mean whole mouth MGI between 1.75 and 2.30.
• Participant with mean whole mouth TPI score ≥1.5.
• Participant with a minimum of 20 bleeding sites.

You may not qualify if:

• 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 Consumer Healthcare (GSKCH) employee directly involved in the conduct of the study or a member of their immediate family.
• 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.
• 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.
• Participant with any other clinical serious or unstable conditions (e.g. cardiovascular diseases, diabetes, liver disorders and kidney disorders) which may affect study outcomes and/ or participant safety.
• Participant who is a pregnant female (including a woman who has a positive urine pregnancy test; pregnancy testing will be carried out for all female participants who are of childbearing potential) or is intending to become pregnant over the duration of the study.
• Participant who is a breastfeeding female.
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Participant unwilling or unable to comply with the Lifestyle Considerations described below:
• Dental Product/Treatment and Oral Hygiene Restrictions From Screening (Visit 1) to the Participant's Last Study Visit • Participants should not use any other oral care products (e.g. dentifrices, toothbrushes, mouthrinses) other than those provided during the study.
• Participants should not carry out any interproximal dental cleaning. Use of dental floss, toothpicks, waterpicks or inter-dental brushes is prohibited (except for the removal of impacted food with non-antimicrobial products only).
• Participants should delay any non-emergency dental treatment until after study completion (including dental prophylaxis).
• Before Clinical Efficacy Assessment Visits: Baseline (Visit 2) to Last Study Visit • Participants should refrain from oral hygiene procedures for 12 hours ((+6hr, -2hr) before their visit and attend the study site with overnight plaque growth.
• Dietary and Smoking Restrictions From Screening (Visit 1) to the Participant's Last Study Visit • Participants should not chew gum or consume any confectionery containing xylitol (e.g. mints).
• Participants must abstain from smoking/ use of tobacco products (e.g. chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes).
• Before Clinical Efficacy Assessment Visits: Baseline (Visit 2) to Last Study Visit

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Mississauga, Ontario, L4W 0C2, Canada

Location

Related Publications (1)

• Axe A, Patel N, Qaqish J, Ling MR, Araga M, Parkinson C, Goyal CR. Efficacy of an experimental toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride on gingivitis. BMC Oral Health. 2024 Feb 9;24(1):209. doi: 10.1186/s12903-024-03981-9.

  PMID: 38336635 DERIVED

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

8664357343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2021
• First Posted: February 4, 2021
• Study Start: February 10, 2021
• Primary Completion: July 28, 2021
• Study Completion: July 28, 2021
• Last Updated: January 19, 2024
• Results First Posted: January 19, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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 grant-ed, when justified, for up to another 12 months.

Locations

CA (1)