Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

Orthodontic, Interproximal Enamel Reduction Clinical Trial

— IER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02455700
• Other study ID #: IER V1 06.03.2015
• Status: Recruiting
• Phase: N/A
• First received: May 20, 2015
• Last updated: April 26, 2017
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: Gursharan Minhas, MOrth
• Phone: 00441483 406 623
• Email: gursharanminhas[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic, Interproximal Enamel Reduction

Intervention

Device:
• Interproximal Enamel Reduction
removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment

Locations

Country	Name	City	State
United Kingdom	RSCH	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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