Switching toothpastes and gum health in people with gingival inflammation

A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

This will test whether switching from a proven gum‑health toothpaste to a regular fluoride toothpaste changes gum inflammation, bleeding, and plaque in adults with gingival problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Unilever R&D (industry)
• Locations: 1 site (Jakarta Pusat)
• Trial ID: NCT07415733 on ClinicalTrials.gov

What this trial studies

This double-blind, randomized, parallel-group trial will enroll at least 150 adults with gingival inflammation and bleeding and randomize them to use one of two toothpastes twice daily for 13 weeks. After 13 weeks participants switch to a fluoride toothpaste without gum-health actives for an additional 4 weeks to observe any change after stopping the active. Clinical assessments of gingival condition, plaque levels, and bleeding on probing will be done at baseline and Weeks 4, 13, and 17, with gingival crevicular fluid and supragingival plaque samples collected for biomarker and microbiome analysis. The OHIP-14-PD questionnaire will capture oral health–related quality of life.

Who should consider this trial

Good fit: Adults with gingival inflammation and bleeding who have at least 20 natural teeth (including five assessable teeth per quadrant), a whole-mouth bleeding-on-probing ≥10%, and the ability to follow study instructions would be ideal candidates.

Not a fit: People with advanced untreated periodontal disease, fewer than 20 natural teeth, recent use of gum‑health products, current participation in other dental trials, or who are pregnant or breastfeeding may not receive benefit from this protocol.

Why it matters

Potential benefit: If successful, the results could show whether the gum‑health toothpaste provides sustained reductions in gingival inflammation, bleeding, and plaque compared with a regular fluoride toothpaste.

How similar studies have performed: Previous randomized trials of toothpastes containing gum‑health actives have reported reductions in gingival inflammation and bleeding versus controls, so the general approach has supporting evidence.

Eligibility criteria

Inclusion Criteria:

* Participants need to be competent i.e., able to understand what is to take place and able to provide a free decision on agreeing to the activity/taking part in the study on this.
* Participants must be able to read and understand study instructions and any other relevant study documents.
* Have at least 20 natural teeth without subgingival calculus, including 5 assessable teeth (excluding 3rd molars) in each quadrant.
* Have a mean whole mouth BOP ≥ 10% at screening.
* Willing to follow the lifestyle and dietary restrictions as detailed in the Information Sheet for study.

Exclusion Criteria:

* Be pregnant or breastfeeding.
* Participants who participated in gum health study within 3 months prior to screening.
* Current participation in any other cosmetic studies, any dental clinical studies or clinical trials.
* Participants who have used any gum health products in the 4 weeks prior to screening.
* Obvious signs of untreated caries or significant periodontal disease, which in the opinion of the study dentist, will affect either the scientific validity of the study or if the participant to take part in the study would affect their wellbeing.
* Have more than three sites with a probing pocket depth (PPD) of ≥ 5 mm.
* Full or partial dentures wearers.
* Current orthodontic treatment.
* Smokers or those who have a recent smoking history, including e-cigarettes.
* Diabetics.
* Have had a dental prophylaxis in the month prior to enrolment or have one scheduled prior to the end of the study.
* Medical condition and/or regular use of any medication which might affect the outcome of the study, as determined by the study dentist, principally a course of anti-inflammatory, antimicrobial or statin drugs within 4 weeks of screening.
* Taking dietary supplements (e.g. multivitamins, antioxidants, fish oils, etc.).
* Known allergy to any ingredient in study products.
* The participant is a Unilever employee or a member of the study team.
* Any participant who, in the judgement of the investigator, should not participate in the study.

Where this trial is running

Jakarta Pusat

• Faculty of Dentistry, University of Indonesia — Jakarta Pusat, Indonesia (RECRUITING)

Study contacts

• Study coordinator: Associate Prof. Benso Sulijaya

Conditions: Gingival Inflammation, Gingival Bleeding, Dental Plaque