NCT07259642

Comparison of Different Debonding Techniques of Clear Aligner Attachments

Clinical Comparison of Different Debonding Techniques of Clear Aligner Attachments: A Single-center, Split-Mouth Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to compare two different methods for removing clear aligner attachments from tooth surfaces and to evaluate the pain levels and removal times associated with each method. The main questions this study aims to answer are: * Does the use of an adhesive removal plier result in less pain compared to using a tungsten carbide bur? * Is there a difference in the time required to remove attachments between the two methods? In this split-mouth, randomized clinical trial, participants who have completed clear aligner treatment will undergo two different attachment removal techniques: * Plier method: Attachments will be removed using adhesive removal pliers, followed by finishing with a tungsten carbide bur. * Bur method: Attachments will be removed entirely using a tungsten carbide bur. Pain levels will be assessed using an 11-point Numeric Rating Scale (NRS) after each segment is treated, and the time required for each removal will be recorded. The amount of adhesive remaining on the enamel surface will also be evaluated. This study aims to determine which debonding technique provides a faster and more comfortable experience for patients at the end of aligner treatment.

Detailed description

This study was conducted to compare two different debonding techniques used for removing clear aligner attachments and to evaluate their effects on pain perception, removal time, and adhesive remnants on the enamel surface. Clear aligner attachments are routinely used to enhance tooth movement, and their removal at the end of treatment should be efficient, safe, and comfortable for patients. However, there is limited clinical evidence evaluating patient-centered outcomes. This single-center, split-mouth, randomized clinical trial included participants who had completed clear aligner treatment or the first set of clear aligners and required removal of composite attachments. Each participant received both debonding techniques in diagonally opposite quadrants to allow direct comparison within the same individual. In the plier technique, attachments were mechanically disengaged using adhesive removal pliers, followed by refinement of the enamel surface with a 24-blade tungsten carbide finishing bur. In the bur technique, attachments were completely removed using a 24-blade tungsten carbide bur without prior mechanical detachment. All procedures were performed at low speed and without water cooling. Pain intensity was assessed immediately after debonding each segment using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable), where higher scores indicate worse pain. Removal time for each attachment was recorded using a digital timer. Adhesive remnants were evaluated using a modified Adhesive Remnant Index (ARI) scored from 0 to 2. Additional analyses examined whether pain scores differed by age, gender, and attachment type (optimized vs. conventional). The overall aim of this study was to provide clinically relevant evidence to guide orthodontists in selecting an attachment removal technique that maximizes patient comfort, improves clinical efficiency, and minimizes adhesive remaining on the enamel surface at the end of clear aligner therapy.

Conditions

• Orthodontic Pain (D013850)
• Orthodontic Patient Experience
• Orthodontic Aligners
• Orthodontic

Interventions

Type	Name	Description
PROCEDURE	Adhesive removal plier followed by tungsten carbide bur	In this intervention, clear aligner attachments are removed using an adhesive removal plier with a controlled torquing motion. After mechanical detachment of the attachments, any remaining adhesive resin is removed using a 24-blade tungsten carbide finishing bur operated at low speed (20,000 rpm) without water cooling. This combined approach aims to minimize discomfort by reducing contact time with rotary instruments while ensuring complete adhesive removal. Pain levels are evaluated immediately after debonding each segment using an 11-point Numeric Rating Scale (NRS). Adhesive remnants are scored using a modified Adhesive Remnant Index (ARI) before bur refinement.
PROCEDURE	Tungsten carbide bur	In this intervention, clear aligner attachments are completely removed using a 24-blade tungsten carbide bur operated at low speed (20,000 rpm) without water cooling. No plier is used in this method. Pain levels are evaluated immediately after debonding each segment using an 11-point Numeric Rating Scale (NRS). This continuous rotary technique represents a conventional clinical approach for attachment removal.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2025-12-02
• Last updated: 2025-12-02

Locations

1 site across 1 country: Turkey (Türkiye)