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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02455700
Acronym
IER
Enrollment
34
Registered
2015-05-28
Start date
2016-01-31
Completion date
2018-01-31
Last updated
2017-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic, Interproximal Enamel Reduction

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.

Interventions

DEVICEInterproximal Enamel Reduction

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

Sponsors

Royal Surrey County Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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 participantTwo consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months

Secondary

MeasureTime frame
Level of pain experienced with respect to age and gender of participant as assessed by the visual analogue scaleTwo consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months

Countries

United Kingdom

Contacts

Primary ContactGursharan Minhas, MOrth
gursharanminhas@nhs.net00441483 406 623

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026