Effect of Finishing Clear Aligner Marginal Termination Design (Supragingival vs Juxtagingival) on… (NCT07628491) | Clinical Trial Compass
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Effect of Finishing Clear Aligner Marginal Termination Design (Supragingival vs Juxtagingival) on Aligner Color Stability After 14 Days of Wear: A Split-Mouth Study
Romania50 participantsStarted 2026-06-15
Plain-language summary
* The goal of this clinical study is to learn whether the gumline edge design of a finishing orthodontic clear aligner affects how much the aligner's color changes after 14 days of wear.
* The main question is: does a supragingival edge design - a straight edge covering about 2 mm of gum tissue - lead to a different amount of color change in the aligner compared with a juxtagingival edge design that follows the gumline exactly, after 14 days of wear?
* Each participant wears finishing clear aligners with both edge designs at the same time - one design on the upper jaw and the other on the lower jaw - and serves as their own comparison (split-mouth). This within-person approach removes differences between individuals in oral hygiene, diet, and saliva.
* The aligner's color over six selected teeth (three upper, three lower) is measured with a dental spectrophotometer (VITA Easyshade V) at placement (day 0) and after 14 days. Each measurement is repeated three times under standardized optical conditions. The amount of color change is expressed as a color-difference value (ΔE).
* The study hypothesis is that marginal termination design (supragingival versus juxtagingival) is associated with a difference in the 14-day colorimetric change (ΔE00) of the finishing aligner.
* The study is carried out during the finishing (refinement) stage of orthodontic treatment, when only small residual tooth movements remain, so that color changes can be attributed to wear and edge design rather than to tooth movement.
Who can participate
Age range
15 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:
* Adolescent and adult patients (age 15 years or older at enrollment)
* Undergoing a finishing (refinement) stage of clear aligner therapy, with only small residual tooth movements remaining, including both patients completing active orthodontic treatment and patients with prior orthodontic treatment who require additional refinement (e.g., minor relapse or loss of retention)
* Adherence to the prescribed oral hygiene instructions
* Written informed consent; for participants aged 15-17 years, written consent from a parent or legal guardian
Exclusion Criteria:
* Deficient oral hygiene
* Excessive consumption of intensely staining beverages (coffee, tea, red wine, colored carbonated drinks)
* Systemic conditions or medications that may affect salivary secretion or tooth color
* Non-compliance with the aligner / orthodontic appliance wear 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
Aligner Color Change (ΔE00) After 14 Days of Wear
Timeframe: Day 0 and day 14
Trial details
NCT IDNCT07628491
SponsorGeorge Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures