Bioadhesive Film of Acmella Oleracea (Jambu) in the Reduction of Post-bleaching Dental Sensitivit… (NCT07478640) | Clinical Trial Compass
CompletedPhase 3
Bioadhesive Film of Acmella Oleracea (Jambu) in the Reduction of Post-bleaching Dental Sensitivity Caused by Bleaching With 35% Hydrogen Peroxide.
Brazil72 participantsStarted 2024-04-01
Plain-language summary
Despite the wide range of desensitizing agents available on the market, there is still no gold standard treatment that is fully effective in managing sensitivity by dental bleaching. In this context, a bioadhesive film containing Acmella oleracea (jambu)-a natural product with anti-inflammatory and, most notably, analgesic properties-may represent an effective alternative for controlling this discomfort. Therefore, this project aims to clinically evaluate the efficacy of an Acmella oleracea extract bioadhesive film on tooth sensitivity induced by 35% hydrogen peroxide bleaching.
Who can participate
Age range
18 Years – 40 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 must have at least 28 teeth in the cavity
* good oral and general health
Exclusion Criteria:
* active caries or periodontal disease
* visible cracks in front teeth upper or lower
* with evident malocclusion
* restorations and prosthetics in teeth anterior teeth
* gastroesophageal disorders
* severe internal tooth discoloration (tetracycline , fluorosis or pulped teeth)
* dentin exposure in anterior teeth and /or later
* parafunctional habits
* tooth sensitivity
* whitening treatment prior to or undergoing orthodontic treatment
* Furthermore, smokers, pregnant or breastfeeding women do not will be included.
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.
1This trial used a bioadhesive film made from the Jambu plant to try to reduce tooth sensitivity after 35% hydrogen peroxide bleaching — is that an approach you think is worth discussing for my situation, given that the trial is now completed and results may be available?
2Since this was a Phase 3 trial, what does that mean for how much we know about the safety and effectiveness of this Jambu-based film compared to other methods already used to manage post-bleaching sensitivity?
3The trial specifically looked at sensitivity caused by 35% hydrogen peroxide, which is a high-concentration in-office bleaching agent — is that the type of whitening you would recommend for me, or is a lower-concentration option a safer starting point?
4Now that this trial is completed, has the data been published anywhere you could review, so we can understand whether the Jambu film actually reduced sensitivity compared to whatever it was tested against?
5Are there already standard treatments or products proven to reduce tooth sensitivity after professional bleaching that I should consider first, before thinking about anything studied in this trial?
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
Degree of tooth sensitivity after teeth whitening with hydrogen peroxide.
Timeframe: immediately after the procedure and during a 21-day treatment period.