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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiyadh Elm University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older with full permanent dentition.

Undergoing clear aligner therapy (Invisalign) with a ClinCheck treatment plan that includes interproximal enamel reduction (IPR).

Periodontally healthy at baseline (per clinic screening).

Disqualifiers

Orthodontic treatment plan including extractions.

Proximal restorations or caries on any tooth surface targeted for IPR.

Current smoking.

Diabetes mellitus or other systemic diseases known to affect periodontal status.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Arm

    Procedure/Surgery

    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

  • Motor Driven Arm

    Procedure/Surgery

    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)

  • Abrasive Arm

    Procedure/Surgery

    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)

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Manual armExperimental treatment 1 intervention
Group B: Motor-driven armExperimental treatment 1 intervention
Group C: Abrasive armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Accuracy of interproximal enamel reduction (IPR) (planned vs performed, mm)

Planned IPR (mm) will be extracted from the participant's initial digital treatment plan (ClinCheck) for the contacts scheduled for IPR at the study visit. Performed IPR (mm) will be quantified using intraoral scans obtained immediately before and immediately after IPR. STL files will be analyzed in OrthoCAD to measure the mesiodistal tooth widths of incisors, canines, and premolars receiving IPR. The amount of performed IPR will be calculated as the difference in the summed mesiodistal widths of the included teeth before vs after IPR (pre-IPR minus post-IPR). IPR accuracy will be calculated per participant as the discrepancy between planned and performed IPR (mm) and compared across the three groups.

Time frame
Baseline (pre-IPR intraoral scan) to immediately after IPR (post-IPR intraoral scan), same visit

Secondary outcomes

1

Changes in plaque Index

Plaque will be assessed using the Plaque Index of Silness and Löe (1964) on four surfaces per tooth with scores summed and divided by four to obtain the tooth-level plaque index

Time frame
Baseline (pre-IPR) to 6 weeks after IPR.
2

Changes in gingival bleeding index

Bleeding on probing will be assessed at six sites per tooth using gentle probing force of approximately 25 g and scored as 0 for absence of bleeding and 1 for presence of bleeding within 10-15 seconds.

Time frame
Baseline (pre-IPR) to 6 weeks after IPR.

Other outcomes

Sponsors and contacts

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