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

NCT07377825 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2026-01-30

No results posted yet for this study

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

Conditions

  • Dental Crowding,Interproximal Enamel Reduction
  • Malocclusion, Angle's Class
  • Periodontal Diseases

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)

Sponsors & Collaborators

  • Riyadh Elm University

    lead OTHER

Principal Investigators

  • omar alkadhi · Riyadh Elm University

  • Abdulwahab Ahmed Alamri · Riyadh Elm University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2026-09-30
Completion
2026-11-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07377825 on ClinicalTrials.gov