Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

Study Overview
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Brief Summary
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Prospective randomised crossover trial to assess if there is a difference in the level of pain experienced by orthodontic patients undergoing interpromixal enamel reduction at the lower incisor region using either a motor driven reduction device or a hand held device

Detailed Description
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Consenting participants will be randomly allocated to one of the two groups ( motor driven device or hand driven device). A pain questionnaire in the form of a Visual Analogue Scale will be used before the treatment to determine a baseline level of pain and after the chosen treatment to determine the effect or the intervention on pain experience. After a washout period of 6 weeks the participants will crossover to have the opposite intervention carried out. A VAS will be filled in before and after the intervention again to determine a baseline pain score and pain score associated with the intervention. The data will be gathered and entered electronically into a statistical package whereby appropriate statistics will be carried out to determine if there is a significant difference in pain experienced between the two methods of enamel reduction. A secondary aim willl be to determine if there is any correlation with pain experienced and age or gender.

Official Title
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A Hospital Based Prospective Randomised Controlled Clinical Trial Comparing Pain Experience Using Manual and Rotary Interproximal Enamel Reduction Techniques in Orthodontic Patients

Conditions
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Orthodontic, Interproximal Enamel Reduction

Intervention / Treatment
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* Device: Interproximal Enamel Reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years Requiring IER in the lower anterior teeth as part of treatment plan mild crowding in the lower incisor region centreline discrepancy discrepancy between the arches mild and thus requiring IPR to correct incisor position requiring IER for arch coordination No medications Willing to participate Exclusion Criteria: Under 18 years of age Not requiring IER moderate or severe crowding necessitating extraction for relief of crowding patients with removable appliances as their only mode of treatment Patient taking medication Not willing to participate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hand driven enamel reduction<br>This group will have enamel reduction in the lower incisor region carried out using hand held devices | Device: Interproximal Enamel Reduction<br>* removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment<br>* Other names: interdental stripping;|
| Active Comparator: Rotary ( motor driven) device<br>This group will ahve enamel reduction in the lower incisor region carried out using a rotary (motor driven) device | Device: Interproximal Enamel Reduction<br>* removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment<br>* Other names: interdental stripping;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of pain associated with each type of enamel reduction technique will be measured using a 100mm visual analogue scale which will be filled out by participant |  | Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain experienced with respect to age and gender of participant as assessed by the visual analogue scale |  | Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months |