Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem (NCT07415733) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
Indonesia150 participantsStarted 2026-02-27
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 schedu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in gingival condition as measured by Gingival Index
Timeframe: Baseline, Week 17
2
Change in plaque level as measured by Full Mouth Plaque Score
Timeframe: Baseline, Week 17
3
Change in gingival bleeding measured by Bleeding on Probing