RecruitingNot ApplicableNCT07415733

Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem

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

Sponsor

Unilever R&D

Enrollment

150 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

Gingival bleeding Gingival inflammation Dental Plaque

Summary

The primary objective of this clinical study is to evaluate the impact on gingival health when participants switch to a fluoride toothpaste without gum-health actives for 4 weeks after using a proven gum-health toothpaste for 13 weeks.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

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 Criteria16

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.