Evaluation of In-office Bleaching-induced Sensitivity With 2 or 7 Days Interval Between Sessions (NCT06394557) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of In-office Bleaching-induced Sensitivity With 2 or 7 Days Interval Between Sessions
Brazil47 participantsStarted 2023-08-14
Plain-language summary
Clinical randomized single-blind trial, used to measure the level of tooth sensitivity (TS) after in-office dental bleaching sessions, on volunteers using a modified visual analog scale (VAS). The investigators selected for this study, 47 participants with color 2M2 or darker (Using 0M1 - 5M3 Vita bleaching shade guide). The investigators performed two bleaching sessions with an acidic 35% hydrogen peroxide gel with either a 1-week or 2-day interval. The investigators recorded the TS up to 48 h with a VAS scale and the color at baseline and 30 days after bleaching with a value-oriented shade guide and a spectrophotometer. The risk and intensity of TS and the color change were compared between the two groups.
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:
The selected volunteers should:
* Present Good general state of health
* Be at least 18 years of age
* Have an acceptable oral hygiene
* Present the upper and lower arches without absence of teeth of first premolar right to the left first premolar.
* Have anterior teeth with any kind of restoration.
* Be No smoker
* Have the upper right canine with color 2M2 or darker
Exclusion Criteria:
The selected volunteers should not:
* Have medical history of diseases that can affect the results of the study
* Have made use of cigarettes in the last 30 days
* Have some important pathology in the oral cavity
* Be pregnant
* Be breastfeeding
* Have moderate advanced periodontal disease;
* Have consumed drugs, alcohol or any medication that can cover the results, as other types of anti-inflammatories or painkillers;
* Have used products indicated for dental sensitivity, as desensitizing toothpaste or similar product
* Present gingival recession
* Present exacerbated hypersensitivity history
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
Tooth sensitivity
Timeframe: 1 hour after dental bleaching session
2
Tooth sensitivity
Timeframe: 24 hours after dental bleaching session
3
Tooth sensitivity
Timeframe: 48 hours after dental bleaching session