Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation (NCT07591454) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation
30 participantsStarted 2026-06-01
Plain-language summary
Patients seeking fixed orthodontic treatment that requires band placement will be enrolled in this study. This trial aims to compare the efficiency of rectangular cross-section nickel-titanium separators with elastomeric separators in creating sufficient interdental space for orthodontic band placement. In addition, the impact of both separator types on pain perception and gingival health during a 3-day placement period will be evaluated. Participants will be allocated to two groups in a split-mouth design. On the experimental side, nickel-titanium separators will be used, while elastomeric separators will be used as the control on the other side. Outcomes will include separation efficacy, pain perception over time, gingival inflammation, analgesic consumption, and separator loss.
Who can participate
Age range
16 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:
* Class I skeletal and dental malocclusion.
* No history of previous orthodontic treatment.
* All permanent teeth in both arches, except third molars.
* Good oral hygiene and periodontal health.
* Good interproximal tooth contacts at the site of separator placement as
* checked by interdental floss.
* No caries or restorations on the proximal surfaces of first and second permanent molars, and second premolars.
Exclusion Criteria:
* Patients presenting with restorations or carious lesions on the proximal surfaces of the first or second molars or the second premolars.
* Patients with uncontrolled gingival or periodontal inflammation.
* Patients with a history of previous orthodontic treatment.
* Patients are skeletally classified as Class II or Class III.
* Patients are currently using opioid analgesics or have chronic pain conditions requiring regular analgesic intake.
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
Pain Perception
Timeframe: At 4, 24, 48, and 72 hours after separator placement.
2
Separation efficacy
Timeframe: At 72 hours after separator placement, at the time of separator removal
3
Gingival inflammation
Timeframe: At baseline, before separator placement, and immediately before separator removal, 72 hours after separator placement