Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customiz… (NCT07464197) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of Dental Bleaching Using Different Designs of 3D-Printed and Conventional Customized Nightguards
Spain40 participantsStarted 2022-05-01
Plain-language summary
This randomized, double-blind, split-mouth clinical trial evaluates the effectiveness of at-home dental bleaching using customized nightguards fabricated by digital (3D-printed CAD-CAM) and conventional methods, with and without reservoirs. Adult participants with good general and oral health and a baseline tooth shade of A2 or darker undergo bleaching with 10% carbamide peroxide. Outcomes include tooth color change (subjective and spectrophotometric measures), tooth sensitivity, gingival irritation, patient comfort, and patient satisfaction over time.
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:
* Adults aged 18 years or older
* Good general and oral health
* No current medical treatment (self-reported)
* No need for surgical, endodontic, periodontal, or restorative dental treatment
* At least six upper and six lower anterior teeth free of caries and restorations
* Maxillary central incisors with baseline shade A2 or darker
* Willingness to follow the study protocol and use the study-provided oral hygiene products/instructions
Exclusion Criteria:
* Previous tooth bleaching treatment
* Orthodontic appliances or prostheses that interfere with treatment
* Severe intrinsic discoloration (e.g., tetracycline staining, fluorosis, or endodontically treated teeth with discoloration)
* Pregnancy or lactation
* Bruxism
* Gingival recession, dentin exposure, visible enamel cracks, or other conditions associated with increased sensitivity
* Use of anti-inflammatory or analgesic medication during the study period (according to protocol)
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 color change (spectrophotometer; ΔE*ab)
Timeframe: T0 (baseline, Day 0); T1 (Week 1); T2 (Week 2); T3 (Week 3); T4 (Week 4); T5 (Week 6, end of bleaching); T6 (Week 8, 2 weeks post-bleaching).