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New treatment option for Gingival Inflammation
Official title Evaluation of a Toothpaste Containing a Gum Health Active in Participants With Gingival Problem
ClinicalTrials.gov ID: NCT07415733
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Have more than three sites with a probing pocket depth (PPD) of ≥ 5 mm.
See the full eligibility 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jakarta Pusat, Indonesia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jakarta Pusat, Indonesia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.