Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT (IER)

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

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

Study Overview

• Status: Unknown
• Conditions: Orthodontic, Interproximal Enamel Reduction
• Intervention / Treatment: Device: Interproximal Enamel Reduction

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 Type: Interventional
• Enrollment (Anticipated): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Guildford, United Kingdom, GU2 7XX
    • Recruiting
    • RSCH
    • Contact: Gursharan Minhas, MOrth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Gursharan Minhas, MOrth, Royal Surrey County Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (ANTICIPATED): January 1, 2018
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 23, 2015
• First Posted (ESTIMATE): May 28, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: IER V1 06.03.2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No