Actively Recruiting
A Randomized Clinical Study on the Effect of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Led by Unilever R&D · Updated on 2026-04-30
150
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects on gum health when participants switch from a toothpaste containing a gum-health active ingredient to a fluoride toothpaste without these actives. This study focuses on people with gingival problems, aiming to understand changes in gum condition, plaque levels, and bleeding over a total period of 17 weeks. The trial uses a double-blind, randomized, controlled design to compare two types of toothpaste in adults. Participants will be randomly assigned to use one of two toothpastes twice daily at home for 13 weeks: one containing a gum-health active and fluoride, and the other a fluoride toothpaste without gum-health actives. After this period, all participants will switch to the fluoride toothpaste without gum-health actives for an additional 4 weeks. The study includes dental assessments and sample collections at baseline, 4, 13, and 17 weeks to evaluate gum health and oral bacteria. During the study, participants will undergo dental exams measuring gingival condition, plaque, and bleeding on probing. Samples of gingival crevicular fluid and plaque will be collected to assess biomarkers and microbial changes. They will also complete a questionnaire about oral health impact related to periodontal disease. The study monitors these outcomes to assess changes in gum health and oral condition over the 17-week period.
CONDITIONS
Brief Title
Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be able to understand the study and freely agree to take part.
- Participants must be able to read and understand study instructions and documents.
- Have at least 20 natural teeth, including 5 assessable teeth (excluding 3rd molars) in each quadrant.
- Have a mean whole mouth bleeding on probing (BOP) of 10% or more at screening.
- Willing to follow lifestyle and dietary restrictions detailed in the study information sheet.
You will not qualify if you...
- Pregnant or breastfeeding individuals.
- Participation in any gum health study within 3 months prior to screening.
- Current participation in other cosmetic or dental clinical studies or trials.
- Use of any gum health products within 4 weeks prior to screening.
- Untreated dental caries or significant periodontal disease affecting study validity or participant wellbeing.
- More than three sites with probing pocket depth (PPD) of 5 mm or greater.
- Wearing full or partial dentures.
- Undergoing orthodontic treatment.
- Current smokers or recent smoking history, including e-cigarettes.
- Diagnosis of diabetes.
- Dental prophylaxis within 1 month prior to enrolment or scheduled before study end.
- Medical conditions or medications that might affect study outcomes, including recent anti-inflammatory, antimicrobial, or statin drugs.
- Use of dietary supplements such as multivitamins or antioxidants.
- Known allergy to any ingredient in the study products.
- Unilever employees or study team members.
- Any other condition judged by the investigator to prevent study participation.
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 13 weeks
Participants use assigned toothpaste containing either a gum health active or fluoride at home twice daily.
Dental assessments and sample collections at baseline, Week 4, and Week 13
Duration - 4 weeks
Participants switch to using a fluoride toothpaste without gum-health actives for additional observation.
Dental assessments and sample collections at Week 17
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry, University of Indonesia
Jakarta Pusat, Indonesia, 10430
Actively Recruiting
Research Team
A
Associate Prof. Benso Sulijaya
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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