Clinical trial NCT02455700: Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT
Official title: A Hospital Based Prospective Randomised Controlled Clinical Trial Comparing Pain Experience Using Manual and Rotary Interproximal Enamel Reduction Techniques in Orthodontic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic, Interproximal Enamel Reduction
Lead sponsor: Royal Surrey County Hospital NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months
Secondary outcomes:
measure: Level of pain experienced with respect to age and gender of participant as assessed by the visual analogue scale
timeFrame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months
Other outcomes:
Locations:
city: Guildford
country: United Kingdom
facility: RSCH
Study officials:
affiliation: Royal Surrey County Hospital NHS Foundation Trust
name: Gursharan Minhas, MOrth
role: PRINCIPAL_INVESTIGATOR
References: