Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation

Starting soon · Not applicable

Conditions studied: Orthodontic Pain (D013850), Malocclusion, Orthodontic Treatment

In brief

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.

Key facts

Study ID

NCT07532044

Run by

Islamabad Medical and Dental College

People needed

144

Starts

2026-04-10

Expected to finish

2028-04-10

Last updated by the study team

2026-05-08

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Islamabad Dental Hospital — Islamabad, Federal, Pakistan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.