Orthodontic, Interproximal Enamel ReductionIERNCT02455700
Pain Associated With Interproximal Enamel Reduction in Orthodontics: a RCT
A study testing Interproximal Enamel Reduction in people with Orthodontic, Interproximal Enamel Reduction, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthodontic, Interproximal Enamel Reduction
- What is being tested?
- Interproximal Enamel Reduction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
RSCH
Guildford, GU2 7XX
Gursharan Minhas, MOrth
About this study
Official title: A Hospital Based Prospective Randomised Controlled Clinical Trial Comparing Pain Experience Using Manual and Rotary Interproximal Enamel Reduction Techniques in Orthodontic Patients
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
Read the 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.
- Being tested
- Interproximal Enamel Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interproximal Enamel ReductionDevice
Also called interdental stripping
removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment
| Study group | Role | What they receive |
|---|---|---|
| Hand driven enamel reduction | Active comparator | This group will have enamel reduction in the lower incisor region carried out using hand held devices Receives: Device: Interproximal Enamel Reduction |
| 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 Receives: Device: Interproximal Enamel Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months
Secondary outcomes (1)
Level of pain experienced with respect to age and gender of participant as assessed by the visual analogue scale
Measured: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic, Interproximal Enamel ReductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niamh O'Rourke, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Gursharan Minhas, MOrth, Principal investigator, Royal Surrey County Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02455700
- Sponsor's protocol ID
- IER V1 06.03.2015
- Acronym
- IER
- Status last verified
- Apr 2017
- First submitted
- 20 May 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41229345
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Hospital Based Prospective Randomised Controlled Clinical Trial Comparing Pain Experience Using Manual and Rotary Interproximal Enamel Reduction Techniques in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT02455700
- Acronym / sponsor ID
- IER / IER V1 06.03.2015
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand driven enamel reduction | Active comparator | Device: Interproximal Enamel ReductionThis group will have enamel reduction in the lower incisor region carried out using hand held devices |
| Rotary ( motor driven) device | Active comparator | Device: Interproximal Enamel ReductionThis group will ahve enamel reduction in the lower incisor region carried out using a rotary (motor driven) device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interproximal Enamel ReductionAlso: interdental strippingremoval of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment | Device | Hand driven enamel reduction, Rotary ( motor driven) device |
Primary outcome
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
Time frame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months
1 secondary outcome
Level of pain experienced with respect to age and gender of participant as assessed by the visual analogue scale
Time frame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- Derived from this study: PubMed 41229345Sudarshan 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.
- Individual participant dataSharing planned: No
Related trials for Orthodontic, Interproximal Enamel Reduction
Recruiting
Evaluation of Dental and Periodontal Health After IPR in Patients in Orthodontic Treatment With Clear Aligners
Dentinal Hypersensitivity, Plaque, Dental
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gursharan Minhas, MOrth principal investigator
Royal Surrey County Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interproximal Enamel Reduction in people with Orthodontic, Interproximal Enamel Reduction, run by Royal Surrey County Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gursharan Minhas, MOrth (00441483 406 623, gursharanminhas@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Two consecutive visits, 6 weeks apart, over a course of orthodontic treatment which usually lasts 18 to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02455700, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.