Sodium Bicarbonate toothpaste efficacy
Research type
Research Study
Full title
300029 - A randomized, controlled, examiner-blind 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
IRAS ID
320327
Contact name
Mizpah Lamptey
Contact email
Sponsor organisation
Haleon formally known as GlaxoSmithKline Consumer Health (GSK CH)
Clinicaltrials.gov Identifier
NCT05654662
Duration of Study in the UK
1 years, 3 months, 0 days
Research summary
GSK markets toothpastes containing 62-67% sodium bicarbonate as specialist gum health toothpastes which facilitate the removal of dental plaque, thereby reducing gum disease. Results from previous studies have demonstrated that toothpastes containing this ingredient reduce plaque and improve gum disease more than standard fluoride toothpastes, but participants in these studies were given a professional clean before the toothpaste was tested this tells us that it works on new plaque. In contrast this study will test if it can help with older plaque. Adults with mild-moderate plaque induced gum disease who consent to take part will be enrolled. After screening, participants gum disease will be assessed (scored) and they will receive a standard fluoride toothpaste to use twice daily for 2 weeks. At baseline, participants gum disease will be re-scored and they will be randomised to one either the sodium bicarbonate test toothpaste or a regular fluoride toothpaste that they will be asked to use twice daily for the 12 weeks instead of their normal toothpaste. Participants will return to the study site again after 3 weeks, 6 weeks and 12 weeks and their gum disease will be assessed. In addition, participants will be asked to complete a diary recording their toothbrushing's from enrolment until the final study appointment. Changes in clinically determined gum inflammation and plaque removal will be assessed at these timepoints.
Researchers wanted to find out how well the study toothpaste helped in gingivitis treatment when the participants brushed their teeth with the toothpaste twice daily for 12 weeks.
To study the effects on gingivitis condition, study doctors performed bleeding index (BI) assessments (from which number of bleeding sites were calculated). During the assessment, a probe was gently inserted into participant’s gums selected by the examiner for evaluation (known as evaluable tooth sites). The sites with no bleeding after 30 seconds were scored as 0; sites with bleeding observed within 30 seconds of probing were scored as 1 and sites with immediate bleeding on probing were scored as 2.
Number of bleeding sites for each participant was calculated as the number of evaluable tooth sites with a BI score of either 1 or 2. Researchers compared the number of bleeding sites at the start of the study, that is at Baseline (Day 0) with the number at Weeks 3, 6 and 12. They also compared the number of bleeding sites between participants in the test product group and the reference product group. A decrease in the number of bleeding sites would indicate an improvement in gingivitis condition.
Findings from this study indicate that participants with mild gingivitis who used the test product containing 67% Sodium Bicarbonate for a long-term duration of 12 weeks had reduced gingivitis and plaque accumulation. These effects were seen as early as 3 weeks.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0285
Date of REC Opinion
4 Jan 2023
REC opinion
Further Information Favourable Opinion