Effect of Andiroba on Control of Post-whitening Tooth Sensitivity (NCT06614764) | Clinical Trial Compass
CompletedNot Applicable
Effect of Andiroba on Control of Post-whitening Tooth Sensitivity
Brazil75 participantsStarted 2024-10-01
Plain-language summary
This randomized clinical trial will evaluate the effect of an experimental gel containing andiroba oil (Carapa guianensis) in reducing postoperative tooth sensitivity caused by bleaching with 35% hydrogen peroxide. Volunteers in this study will be randomized into 3 different groups - PG (placebo gel), KF2G (potassium nitrate gel) and AG (andiroba gel). Groups KF2G and AG will receive treatment with potassium nitrate desensitizing gel and the experimental andiroba gel, respectively. This will be applied to the buccal surfaces of the central incisors, lateral incisors, canines and upper and lower premolars, with a rubber cup in an active manner, for 10 minutes. Group GP will receive the application of a placebo gel (without active ingredient), under the same conditions described for the other groups. Subsequently, all groups will undergo in-office bleaching treatment with 35% hydrogen peroxide. Post-bleaching sensitivity will be collected using a form consisting of the visual analogue scale (VAS). Color measurement will be performed with a spectrophotometer at two times: baseline (T0) and one week after the 3rd bleaching session (T1).
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:
* good oral hygiene
* absence of active caries lesions
* never having undergone previous whitening therapy
* not present dental hypersensitivity
* don\'t be a smoker
* not be pregnant
* present at least 28 teeth in the oral cavity.
Exclusion Criteria:
* volunteers who were under orthodontic treatment,
* presence of periodontal disease
* dental cracks or fractures
* restorations and prostheses on anterior teeth
* extensive molar restorations
* gastroesophageal disorders
* severe internal dental darkening
* presence of dentinal exposure in anterior and / or posterior teeth.
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 tested andiroba — a plant-based oil — as a way to reduce tooth sensitivity after whitening. Is this something worth discussing as an option before or after any bleaching treatment I might have?
2Since this trial is listed as Phase NA and has already been completed, does my dentist have access to the results, and do those results show whether andiroba actually reduced post-whitening pain compared to a standard desensitizing agent?
3I know post-whitening sensitivity can be a real problem for some people — based on what this trial was measuring, how would my dentist assess my personal risk for that kind of pain, and would a desensitizing treatment make sense for me?
4Are there already proven desensitizing agents my dentist uses routinely after tooth whitening, and how would andiroba compare to those in terms of what's currently known about safety and effectiveness?
5If I'm considering tooth whitening, should I wait to see whether findings from this completed trial change my dentist's approach to managing sensitivity, or is there enough existing evidence to move forward with a standard protocol now?
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.