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

Official title

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

Overview

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.

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.

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
• 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

Primary outcome measures

• Amount of Tooth Separation Achieved [Time frame: 48 to 72 hours after separator placement]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Islamabad Dental Hospital — Islamabad

Publications

• 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
• 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
• 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

Identifiers

NCT: NCT07532044 · IDH111 · IDH-ORTHO-2017-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗