Comparison of Different Debonding Techniques of Clear Aligner Attachments

NCT07259642 | Completed

• 1 other identifier: 2024-22-03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Debonding, clear aligner attachment

Outcome Measures

Primary Outcomes (1)

• Pain level during attachment removal

  Pain intensity will be measured immediately after debonding each segment (anterior and posterior) using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain. In group pliers, pain levels were recorded separately after both plier and bur applications for each segment, and the average was calculated to provide a single pain value. In bur group, pain scores were recorded after each segment attachments were completely removed.

  Immediately after debonding each segment

Secondary Outcomes (5)

• Attachment removal time per tooth

  Immediately after debonding each segment

• Adhesive remnants on enamel surface

  Immediately after attachment removal with pliers

• Comparison of pain levels between genders

  Immediately after debonding each segment

• Correlation between age and pain perception

  Immediately after debonding each segment

• Comparison of adhesive remnant index (ARI) according to attachment type (optimized vs. conventional)

  Immediately after debonding using the plier technique

Study Arms (2)

Plier group

EXPERIMENTAL

In this group, clear aligner attachments are removed using adhesive removal pliers , followed by cleaning of residual adhesive with a 24-blade tungsten carbide finishing bur operated at low speed (20,000 rpm) without water cooling.

Procedure: Adhesive removal plier followed by tungsten carbide bur

Bur Group

ACTIVE COMPARATOR

In this group, clear aligner attachments are completely removed using a 24-blade tungsten carbide bur operated at low speed (20,000 rpm) without water cooling.

Procedure: Tungsten carbide bur

Interventions

Adhesive removal plier followed by tungsten carbide bur PROCEDURE

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.

Plier group

Tungsten carbide bur PROCEDURE

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.

Bur Group

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged 18 to 44 years with permanent dentition
• No history of taking medication in the last 24 hours (e.g., painkillers, corticosteroids, and antiflu drugs)
• Patients with no missing teeth except for third molars
• Patients who underwent clear aligner treatment (Invisalign®) without an extraction protocol by one of the co-authors of the present study
• Patients who completed aligner treatment and reached the attachment removal stage
• Patients with at least 4 attachments in each quadrant of the mouth and a total of at least 16 attachments
• Patients in good general and oral health with no periodontal disease

You may not qualify if:

• Patients with endodontic treatment, large restorations, and buccal restorations
• Patients with a history of previous orthodontic treatment
• The presence of systemic diseases that may cause dentin and enamel hypersensitivity
• Patients who underwent surgical treatment and displayed signs of gingival recession
• Patients who received teeth whitening in the last 8 weeks.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry Department of Orthodontics

Ankara, 06230, Turkey (Türkiye)

Location

Study Officials

• Ezgi Atik, Dr.

  Hacettepe University Faculty of Dentistry Department of Orthodontics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: December 2, 2025
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)