An interventional study of Elastomeric Separator and Kesling Separator in Orthodontic Pain (D013850), Malocclusion and Orthodontic Treatment, sponsored by Islamabad Medical and Dental College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 12 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Islamabad Medical and Dental College · Not applicable, Interventional, and Treatment
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.
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.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 144 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Islamabad Medical and Dental College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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.
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.
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.
Time frame: 48 to 72 hours after separator placement
Plan to share: No — IPD will not be shared to maintain participant confidentiality and due to institutional data protection policies.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Islamabad Medical and Dental College