Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

NCT ID: NCT02455700

Last Updated: 2017-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

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.

Conditions

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Orthodontic, Interproximal Enamel Reduction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Hand driven enamel reduction

This group will have enamel reduction in the lower incisor region carried out using hand held devices

Group Type ACTIVE_COMPARATOR

Interproximal Enamel Reduction

Intervention Type DEVICE

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

Rotary ( motor driven) device

This group will ahve enamel reduction in the lower incisor region carried out using a rotary (motor driven) device

Group Type ACTIVE_COMPARATOR

Interproximal Enamel Reduction

Intervention Type DEVICE

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

Interventions

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Interproximal Enamel Reduction

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

Intervention Type DEVICE

Other Intervention Names

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interdental stripping

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Surrey County Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Niamh O'Rourke

Miss G Minhas, Consultant in Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gursharan Minhas, MOrth

Role: PRINCIPAL_INVESTIGATOR

Royal Surrey County Hospital NHS Foundation Trust

Locations

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RSCH

Guildford, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Gursharan Minhas, MOrth

Role: CONTACT

00441483 406 623

Facility Contacts

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Gursharan Minhas, MOrth

Role: primary

Other Identifiers

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IER V1 06.03.2015

Identifier Type: -

Identifier Source: org_study_id

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