Orthodontic Pain (D013850)NCT07259642
Comparison of Different Debonding Techniques of Clear Aligner Attachments
A study testing Adhesive removal plier followed by tungsten carbide bur and Tungsten carbide bur in people with Orthodontic Pain (D013850) and Orthodontic Patient Experience, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain (D013850), Orthodontic Patient Experience, Orthodontic Aligners
- What is being tested?
- Adhesive removal plier followed by tungsten carbide bur and Tungsten carbide bur
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Dentistry Department of Orthodontics
Ankara, 06230
About this study
Official title: Clinical Comparison of Different Debonding Techniques of Clear Aligner Attachments: A Single-center, Split-Mouth Randomized Clinical Trial
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?
Read more
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.
Read the 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
- Being tested
- Adhesive removal plier followed by tungsten carbide bur, Tungsten carbide bur
- Keywords
- Debonding, clear aligner attachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adhesive removal plier followed by tungsten carbide burProcedure or surgery
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.
Tungsten carbide burProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Tungsten carbide bur |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after debonding each segment
Secondary outcomes (5)
Attachment removal time per tooth
The removal time per quadrant was calculated in seconds by a digital timer. The average removal time required per attachment was calculated by dividing the total attachment removal time in each quadrant by the number of attachments present in that quadrant.
Measured: Immediately after debonding each segment
Adhesive remnants on enamel surface
In the Plier group, after debonding attachments with a plier and before removing the residual adhesive with a bur, a modified adhesive remnant index (ARI) was used to evaluate the remaining adhesives using a magnifying dental loupe at 2.5X magnification by two examiners. "0" indicated no adhesive remaining on the tooth, "1" indicated less than half of the adhesive remaining, and "2" indicated more than half remaining. Higher scores indicate more adhesive remaining. If there were discrepancies, a third examiner was asked to make the final determination of the score.
Measured: Immediately after attachment removal with pliers
Comparison of pain levels between genders
NRS pain scores obtained during debonding will be compared between male and female participants to evaluate potential gender-related differences in pain perception.
Measured: Immediately after debonding each segment
Correlation between age and pain perception
The relationship between participants' age and reported NRS pain scores will be analyzed to determine whether pain perception varies by age.
Measured: Immediately after debonding each segment
Comparison of adhesive remnant index (ARI) according to attachment type (optimized vs. conventional)
After attachment removal using the plier technique, the distribution of ARI scores will be compared between optimized and conventional attachment types to determine whether attachment design influences the amount of adhesive remaining on enamel surfaces.
Measured: Immediately after debonding using the plier technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Apr 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Pain (D013850)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Atik, Hacettepe University
- Investigators
- Ezgi Atik, Dr., Principal investigator, Hacettepe University Faculty of Dentistry Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07259642
- Sponsor's protocol ID
- 2024-22-03
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared in order to protect participants' privacy and ensure compliance with institutional and ethical data protection regulations. All collected data contain potentially identifiable information, and therefore will remain confidential and stored securely within the study institution.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of Different Debonding Techniques of Clear Aligner Attachments: A Single-center, Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07259642
- Acronym / sponsor ID
- 2024-22-03
- Conditions
- Orthodontic Pain (D013850), Orthodontic Patient Experience, Orthodontic Aligners, Orthodontic
- Keywords
- Debonding, clear aligner attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plier group | Experimental | Procedure: Adhesive removal plier followed by tungsten carbide burIn 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. |
| Bur Group | Active comparator | Procedure: Tungsten carbide burIn 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. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adhesive removal plier followed by tungsten carbide burIn 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 or surgery | Plier group |
| Tungsten carbide burIn 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. | Procedure or surgery | Bur Group |
Primary outcome
Pain level during attachment removal
Time frame: Immediately after debonding each segment
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.
5 secondary outcomes
Attachment removal time per tooth
Time frame: Immediately after debonding each segment
Adhesive remnants on enamel surface
Time frame: Immediately after attachment removal with pliers
Comparison of pain levels between genders
Time frame: Immediately after debonding each segment
Correlation between age and pain perception
Time frame: Immediately after debonding each segment
Comparison of adhesive remnant index (ARI) according to attachment type (optimized vs. conventional)
Time frame: Immediately after debonding using the plier technique
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared in order to protect participants' privacy and ensure compliance with institutional and ethical data protection regulations. All collected data contain potentially identifiable information, and therefore will remain confidential and stored securely within the study institution.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezgi Atik, Dr. principal investigator
Hacettepe University Faculty of Dentistry Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adhesive removal plier followed by tungsten carbide bur and Tungsten carbide bur in people with Orthodontic Pain (D013850) and Orthodontic Patient Experience, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level during attachment removal (time frame: Immediately after debonding each segment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.