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| ID | Type | Description | Link |
|---|---|---|---|
| IDH-ORTHO-2017-01 | Other Identifier | Islamabad Medical and Dental College |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Prof Dr Haroon Shahid Qazi, BDS, MS, MCPS( HPE) | Islamabad medical & dental College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Islamabad Dental Hospital | Islamabad | Federal | 45720 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21195257 | Result | 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. | |
| 25302266 | 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. |
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IPD will not be shared to maintain participant confidentiality and due to institutional data protection policies.
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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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.
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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.
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| 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. |
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| 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. |
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| 35986458 | 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. |