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NOT YET RECRUITING
NCT07377825
NA

Accuracy and Periodontal Outcomes of Three Interproximal Enamel Reduction Techniques During Clear Aligner Therapy

Sponsor: Riyadh Elm University

View on ClinicalTrials.gov

Summary

This randomized controlled clinical trial will compare three commonly used interproximal enamel reduction (IPR) techniques during clear aligner therapy in adult patients. IPR is a routine orthodontic procedure in which a small amount of enamel is removed between teeth to create space and help achieve the planned alignment. Seventy-five adults (18 years and older) indicated for receiving clear aligner treatment with IPR prescribed in their digital treatment plan will be enrolled at the orthodontic clinics of Riyadh Elm University (Riyadh, Saudi Arabia) and randomized in a 1:1:1 ratio to one of three IPR techniques: manual abrasive strips (manual arm), motor-driven oscillating strips (motor-driven arm), or abrasive discs (abrasive arm). IPR will be performed by the same trained operator according to the assigned technique. The primary outcome is IPR accuracy, defined as the difference between the amount of IPR planned digitally and the amount performed clinically, measured using intraoral scans taken before and immediately after IPR. Secondary outcomes are short-term periodontal outcomes, assessed on IPR teeth only using plaque and gingival bleeding indices at baseline and at a 6-week follow-up visit. The data analyst will be blinded to group allocation

Official title: Accuracy and Periodontal Outcomes of Three Interproximal Enamel Reduction Techniques During Clear Aligner Therapy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

75

Start Date

2026-03

Completion Date

2026-11

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

PROCEDURE

Manual Arm

Interproximal enamel reduction (IPR) will be performed at the contacts prescribed in the participant's digital treatment plan using manual abrasive strips (6 mm separating abrasive strips, coarse; Ortho Organizers, Inc., Carlsbad, USA). IPR will be performed by the same trained and calibrated operator, and interproximal clearance will be verified using metal interproximal gauges

PROCEDURE

Motor Driven Arm

Interproximal enamel reduction will be performed at the prescribed contacts using motor-driven oscillating strips (OK Strips Kit with JAINTEK EVA handpiece operated at \< 15,000 rpm; JAINTEK Co., Ltd., Guri-si, Republic of Korea). IPR will be performed by the same trained and calibrated operator and interproximal clearance will be verified using metal interproximal gauges. (n = 25)

PROCEDURE

Abrasive Arm

Interproximal enamel reduction will be performed at the prescribed contacts using abrasive discs (OK DIA DISC, double-sided, thickness 0.15 mm; JAINTEK Co., Ltd., Guri-si, Republic of Korea). IPR will be performed by the same trained and calibrated operator and interproximal clearance will be verified using metal interproximal gauges. (n = 25)

Locations (1)

Riyadh Elm University

Riyadh, Riyadh Region, Saudi Arabia