Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

Royal Surrey County Hospital NHS Foundation Trust34 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Orthodontic, Interproximal Enamel Reduction

Interventions

Interproximal Enamel ReductionDEVICE

removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

RSCH

Guildford, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months

Secondary Outcomes

Level of pain experienced with respect to age and gender of participant as assessed by the visual analogue scale

Time frame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months

Central Contacts

Gursharan Minhas, MOrth

CONTACT

00441483 406 623 gursharanminhas@nhs.net

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.