Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation (NCT07532044) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation
Pakistan144 participantsStarted 2026-04-10
Plain-language summary
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities.
This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation.
In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort.
Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.
Who can participate
Age range
12 Years – 25 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:
* Patients requiring fixed orthodontic appliance therapy with maxillary first molar banding
* Age between 12 and 25 years
* Good oral hygiene (Plaque Index score 0-1)
* Good general oral health
* No previous orthodontic treatment
* No history of dental extractions
* Presence of tight interproximal contacts at the site of separator placement (no spacing)
Exclusion Criteria:
* Presence of interproximal restorations
* Presence of interproximal caries
* Missing maxillary second premolar, first molar, or second molar
* Unerupted maxillary second molars
* Systemic diseases affecting oral health (e.g., diabetes mellitus)
* Regular use of medications affecting pain perception (e.g., analgesics, corticosteroids)
* Loss of separators before follow-up appointment
* Failure to return within 72 hours for evaluation
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
Amount of Tooth Separation Achieved
Timeframe: 48 to 72 hours after separator placement