Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation (SEP-ORTHO)

May 5, 2026 updated by: Islamabad Medical and Dental College

Separation Effect, Plaque Score, Pain Perception, And Impact On Quality Of Life When Comparing Three Types Of Orthodontic Separators: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Separation of teeth prior to molar banding is an essential step in fixed orthodontic treatment. Orthodontic separators are used to create sufficient interproximal space to allow proper placement of bands. However, separator placement is commonly associated with pain, discomfort, and changes in oral hygiene practices, which may lead to plaque accumulation and negatively impact patients' quality of life.

Various types of orthodontic separators are available, including elastomeric separators, spring-type separators such as Kesling separators, and customized separators such as ligature tie wire separators. Elastomeric separators are widely used due to ease of placement; however, they may cause significant pain and are prone to dislodgement. Kesling separators are effective in tight contact areas but may cause gingival irritation and are relatively difficult to handle. Tie wire separators, which can be fabricated chairside, may offer a cost-effective and practical alternative, especially in cases with tight interproximal contacts.

This randomized controlled trial aims to compare three types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of:

Amount of separation achieved Pain perception using a visual analogue scale (VAS) Plaque accumulation measured using the Silness and Loe plaque index Impact on patients' quality of life assessed through structured interviews

A total of 144 participants requiring fixed orthodontic treatment with molar banding will be randomly allocated into three groups. Separators will be placed on the mesial and distal surfaces of maxillary first molars. Clinical parameters will be assessed after 48-72 hours.

Quantitative data will be analyzed using appropriate statistical tests, including one-way ANOVA and Chi-square tests. Additionally, qualitative data from patient interviews will be analyzed using thematic analysis to explore the impact of separator placement on daily life, including functional, emotional, and social aspects.

The results of this study will help determine the most effective separator with minimal discomfort and adverse effects, thereby improving patient compliance and overall orthodontic treatment experience.

Study Type

Interventional

Enrollment (Estimated)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Prof. Dr Haroon Shahid Qazi, BDS, MS, MCPS(HPE)
  • Phone Number: +92 3005001774
  • Email: haroon77@gmail.com

Study Locations

  • Pakistan
    • Federal
      • Islamabad, Federal, Pakistan, 45720
        • Islamabad Dental Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Elastomeric Separator Group
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
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: 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.
Active Comparator: Kesling Separator Group
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
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.
Experimental: Tie Wire Separator Group
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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of Tooth Separation Achieved
Time Frame: 48 to 72 hours after separator placement
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Islamabad Medical and Dental College

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 10, 2026

Primary Completion (Estimated)

April 10, 2028

Study Completion (Estimated)

April 10, 2028

Study Registration Dates

First Submitted

April 8, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IDH111
  • IDH-ORTHO-2017-01 (Other Identifier: Islamabad Medical and Dental College)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared to maintain participant confidentiality and due to institutional data protection policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malocclusion

Clinical Trials on Elastomeric Separator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe