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

NCT07532044 | Not Yet Recruiting

• 2 other identifiers: IDH111IDH-ORTHO-2017-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Orthodontic separators; Pain perception; Plaque index; Quality of life; Tooth separation

Outcome Measures

Primary Outcomes (1)

• Amount of Tooth Separation Achieved

  Interproximal separation between maxillary first molars measured using a leaf gauge (COMBO TECH incremental thickness gauge) on mesial and distal surfaces. Mean separation will be calculated.

  48 to 72 hours after separator placement

Study Arms (3)

Elastomeric Separator Group

OTHER

Participants will receive elastomeric separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.

Device: Elastomeric Separator; Device: Tie wire separator

Kesling Separator Group

ACTIVE COMPARATOR

participants will receive Kesling (spring-type) separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.

Device: Elastomeric Separator; Device: Kesling Separator

Tie Wire Separator Group

EXPERIMENTAL

Participants will receive customized ligature tie wire separators placed on the mesial and distal surfaces of maxillary first molars to achieve interproximal separation prior to banding.

Device: Kesling Separator; Device: Tie wire separator

Interventions

Elastomeric Separator DEVICE

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.

Elastomeric Separator Group; Kesling Separator Group

Kesling Separator DEVICE

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.

Kesling Separator Group; Tie Wire Separator Group

Tie wire separator DEVICE

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.

Elastomeric Separator Group; Tie Wire Separator Group

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Islamabad Dental Hospital

Islamabad, Federal, 45720, Pakistan

Location

Related Publications (3)

• Patel S, McGorray SP, Yezierski R, Fillingim R, Logan H, Wheeler TT. Effects of analgesics on orthodontic pain. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e53-8. doi: 10.1016/j.ajodo.2010.07.017.

  PMID: 21195257 RESULT

• Malagan MA, P P B, Muddaiah S, Reddy R, Shetty BK, Preetham J, Naduwinmani S, Singh S. Comparison between efficacy of four different types of orthodontic separators. J Clin Diagn Res. 2014 Aug;8(8):ZC41-4. doi: 10.7860/JCDR/2014/9963.4755. Epub 2014 Aug 20.

  PMID: 25302266 RESULT

• Kumar BD, Chandra S, Singh RN, Shahi AK, Sharma S, Singh B. Separation Effect and Perception of Pain and Discomfort from Kesling and Elastomeric Orthodontic Separators: An In Vivo Study. J Contemp Dent Pract. 2022 May 1;23(5):508-512.

  PMID: 35986458 RESULT

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Prof Dr Haroon Shahid Qazi, BDS, MS, MCPS( HPE)

  Islamabad medical & dental College

  STUDY CHAIR

Central Study Contacts

Dr Sofia Riaz, BDS, MDS

CONTACT

+92 346 5001484; sofia.riaz@iideas.edu.pk

Prof. Dr Haroon Shahid Qazi, BDS, MS, MCPS(HPE)

CONTACT

+92 3005001774; haroon77@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor responsible for measuring separation and recording pain scores will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned into three parallel groups. Each group will receive a different type of orthodontic separator (elastomeric, Kesling, or tie wire) placed on the mesial and distal surfaces of maxillary first molars. Outcomes will be assessed after 48-72 hours.

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): April 10, 2028
• Study Completion (Estimated): April 10, 2028
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)