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

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.

Conditions

• Orthodontic Pain (D013850)
• Malocclusion
• Orthodontic Treatment

Interventions

DEVICE

Elastomeric Separator

Elastomeric separators are polyurethane O-shaped orthodontic modules placed interdentally between the mesial and distal surfaces of maxillary first molars. They exert continuous elastic force to create interproximal space prior to molar band placement. In this study, separators will be placed bilaterally and left in situ for 48-72 hours before removal and clinical assessment of separation, pain, and plaque accumulation.

DEVICE

Kesling Separator

Kesling separators are spring-type orthodontic separators fabricated from 0.020-inch stainless steel Australian wire with a helical loop design. The appliance has two arms, one engaging the lingual embrasure and the other positioned beneath the interproximal contact point, providing controlled separation force in areas with tight contact. In this study, Kesling separators will be placed bilaterally on the mesial and distal surfaces of maxillary first molars and left in situ for 48-72 hours prior to removal and clinical evaluation of separation, pain, and plaque accumulation.

DEVICE

Tie wire separator

Tie wire separators are orthodontic separators fabricated using 0.010-0.012 inch stainless steel ligature wire twisted and adapted interproximally around the contact area of posterior teeth. The wire is tightened and positioned to exert gradual separating force between the mesial and distal surfaces of maxillary first molars, facilitating creation of interproximal space for band placement. In this study, tie wire separators will be placed bilaterally and maintained in situ for 48-72 hours prior to removal and assessment of tooth separation, pain, and plaque accumulation.

Sponsors & Collaborators

• Islamabad Medical and Dental College

  lead OTHER

Principal Investigators

• Prof Dr Haroon Shahid Qazi, BDS, MS, MCPS( HPE) · Islamabad medical & dental College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-04-10

Primary Completion

2028-04-10

Completion

2028-04-10

Countries

• Pakistan

Study Locations