NCT07532044

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Islamabad Medical and Dental College · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Orthodontic Pain (D013850)
• Malocclusion
• Orthodontic Treatment

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-04-10
• Primary completion: 2028-04-10
• Completion: 2028-04-10
• First posted: 2026-04-15
• Last updated: 2026-04-15

Locations

1 site across 1 country: Pakistan