Braces prep: study aims to find the most comfortable separator for patients
NCT ID NCT07532044
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares three types of orthodontic separators (elastomeric, Kesling, and customized tie wire) in 144 people aged 12–25 who need braces. Researchers will measure how well each separator creates space between teeth, how much pain it causes, plaque buildup, and effects on daily life like eating and speaking. The goal is to identify the most effective and comfortable option to improve the orthodontic experience.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 144 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 25 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Islamabad Dental Hospital
Islamabad, Federal, 45720, Pakistan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Sound waves vs. tooth pain: can 11-Hz beats soothe orthodontic discomfort?