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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hand driven enamel reduction | Active Comparator | This group will have enamel reduction in the lower incisor region carried out using hand held devices |
|
| Rotary ( motor driven) device | Active Comparator | This group will ahve enamel reduction in the lower incisor region carried out using a rotary (motor driven) device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interproximal Enamel Reduction | Device | removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment |
|
| Measure | Description | Time 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 participant | Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gursharan Minhas, MOrth | Contact | 00441483 406 623 | gursharanminhas@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Gursharan Minhas, MOrth | Royal Surrey County Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSCH | Recruiting | Guildford | GU2 7XX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41229345 | Derived | Sudarshan S, Sherriff M, O'Rourke N, Minhas G. Difference in pain experience between manual and motor-driven methods of interproximal enamel reduction: a single centre randomized controlled trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf074. doi: 10.1093/ejo/cjaf074. |
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