Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

Not Applicable

• Conditions: Orthodontic, Interproximal Enamel Reduction
• Interventions: Device: Interproximal Enamel Reduction

• Registration Number: NCT02455700
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-05-20
• Study First Submitted QC: 2015-05-23
• Study First Posted: 2015-05-28
• Study Start: 2016-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-28
• Primary Completion: 2018-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Hand driven enamel reduction	Interproximal Enamel Reduction	This group will have enamel reduction in the lower incisor region carried out using hand held devices
Rotary ( motor driven) device	Interproximal Enamel Reduction	This group will ahve enamel reduction in the lower incisor region carried out using a rotary (motor driven) device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

RSCH; 🇬🇧 Guildford, United Kingdom