NCT02455700

Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Royal Surrey County Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Orthodontic, Interproximal Enamel Reduction

Interventions

Type	Name	Description
DEVICE	Interproximal Enamel Reduction	removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2015-05-28
• Last updated: 2017-04-28

Locations

1 site across 1 country: United Kingdom