Orthodontic PainNCT07293975
Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) and High-Frequency Vibration in people with Orthodontic Pain, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention. People who have completed orthodontic treatment and need their braces removed can take part. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS) and High-Frequency Vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients scheduled for fixed orthodontic appliance removal.
- Permanent dentition present, including both anterior and posterior teeth.
- Age between 15-35 years.
- Ability to provide informed consent and comply with study procedures.
- General health adequate for routine orthodontic care.
- No history of regular or recent medication intake within the preceding 24 hours, including painkillers, corticosteroids, or anti-flu drugs.
Who cannot join
- Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception.
- Teeth with extensive restorations or prostheses that prevent standard bracket debonding.
- Patients with known allergy or contraindication to TENS or vibration devices.
- Pregnant women.
- Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I.
- Excessive gingival overgrowth that may impede debonding or influence study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry, University of Baghdad
Baghdad
Malak Alsaqqaf, 009647873431704, malak7alsaqqaf@gmail.com
About this study
Official title: Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study
This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention.
People who have completed orthodontic treatment and need their braces removed can take part. Participants will be randomly assigned to one of the three groups. The vibration device will be applied during the braces removal, while TENS will be applied just before the procedure.
Read more
Before the procedure, participants' anxiety will be measured using the Modified Dental Anxiety Scale (MDAS). During and after the procedure, pain will be assessed using a Visual Analog Scale (VAS) from 0 to 100, and participants will rate their satisfaction using a Numerical Rating Scale (NRS) from 0 to 10.
The purpose of this research is to help orthodontists identify the method that makes braces removal less uncomfortable, more tolerable, and more satisfying for patients.
Read the detailed description
This clinical study aims to evaluate and compare the effectiveness and cost-effectiveness of TENS (Dental Pain Eraser) and high-frequency vibration (SureSmile® VPro™) in reducing discomfort during orthodontic bracket removal, improving patient satisfaction, and optimizing efficiency. The study includes a control group, and results are intended to provide evidence-based guidance for orthodontists to enhance the patient experience during debonding procedures.
Participants will be individuals who have completed fixed orthodontic treatment and are scheduled for bracket removal. Before the procedure, their baseline dental anxiety will be assessed. The assigned intervention will be applied either immediately before (TENS) or during (vibration) the bracket removal session. Participants' experiences of pain and satisfaction will be monitored throughout the procedure. Sex and baseline anxiety will be considered in the analysis to evaluate their influence on outcomes. A cost-effectiveness analysis will be performed to determine the most efficient method among the interventions.
The research will be conducted in a standardized clinical setting, adhering to established bracket removal protocols to ensure participant safety and minimize variability. The procedures will be performed by the same operator following consistent techniques.
This study is designed to generate practical insights into pain management during orthodontic debonding, focusing on participant comfort, satisfaction, and procedural efficiency, without compromising the quality of care. The findings may guide future clinical recommendations and improve patient-centered orthodontic practice.
- Conditions
- Orthodontic Pain
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS), High-Frequency Vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
High-Frequency VibrationDevice
High-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | Participants in this arm will receive transcutaneous electrical nerve stimulation (TENS) applied immediately before orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| High-Frequency Vibration (SureSmile® VPro™) | Experimental | Participants in this arm will receive high-frequency vibration applied during orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session. Receives: Device: High-Frequency Vibration |
| No Intervention | No intervention | Participants in this arm will undergo standard orthodontic bracket removal without any additional device. Pain, satisfaction, and procedural efficiency will be assessed during a single session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain During Orthodontic Debonding Measured by VAS
Pain during debonding will be measured immediately after the procedure using VAS 0-100 mm, where 0 = no pain and 100 = worst imaginable pain.
Measured: During and immediately after debonding procedure
Secondary outcomes (4)
Baseline Anxiety
Baseline anxiety will be assessed prior to the debonding procedure using the Modified Dental Anxiety Scale (MDAS).
The MDAS consists of five items, each scored on a 5-point Likert scale as follows:
Not anxious = 1; Slightly anxious = 2; Fairly anxious = 3; Very anxious = 4; Extremely anxious = 5.
The total MDAS score is calculated as the sum of all five items, with a possible range from 5 to 25.
A cut-off score of 19 or above indicates a highly dentally anxious patient, possibly dentally phobic.
Higher scores indicate greater dental anxiety (worse outcome).
Measured: Prior to the debonding procedure
Patient Satisfaction
Satisfaction will be assessed immediately post-procedure using Numeric Rating Scale (0-10) to evaluate comfort and overall acceptance of the method.
Measured: immediately post-procedure
Device Application Time
Device application time will be recorded for each intervention and defined as the duration (in seconds) required to apply the pain reduction method prior to and/or during orthodontic debonding.
Measured: Periprocedural (during the debonding session)
Cost-Effectiveness Analysis
Direct costs, including device cost, consumables, and operator time, will be recorded for each intervention.
Cost-effectiveness ratios will be calculated as cost per unit reduction in pain score (VAS) to compare the efficiency of each pain-reduction method.
Measured: Periprocedural (during the debonding session) and at immediate post-procedure assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start1 Jan 2026
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three groups: TENS, high-frequency vibration, or control. Each participant will undergo a single session in which the assigned intervention is applied. The study is open-label, and all bracket removal procedures are performed by the same operator using standardized techniques to ensure consistency across groups. Baseline dental anxiety and sex will be recorded as covariates for analysis.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malak Ramzi Abdulmoula Alsaqqaf, University of Baghdad
- Investigators
- Ali M. Al-Attar, BDS, MSc, PhD, Principal investigator, University of Baghdad - College of Dentistry - Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293975
- Sponsor's protocol ID
- TENS-VIB-PAIN-2025
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is currently no definitive plan to share Individual Participant Data (IPD). However, IPD may be made available in the future if required by the journal in which the results are published, subject to ethical approval, institutional regulations, and obtaining appropriate patient consent. All shared data will be de-identified to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration for Pain Control During Bracket Debonding: A Clinical Trial Study
- ClinicalTrials.gov ID
- NCT07293975
- Acronym / sponsor ID
- TENS-VIB-PAIN-2025
- Conditions
- Orthodontic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 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.
This study aims to find the best method to reduce pain during braces removal. We are comparing transcutaneous electrical nerve stimulation (TENS), high-frequency vibration, and a control group with no additional intervention.
People who have completed orthodontic treatment and need their braces removed can take part. Participants will be randomly assigned to one of the three groups. The vibration device will be applied during the braces removal, while TENS will be applied just before the procedure.
Before the procedure, participants' anxiety will be measured using the Modified Dental Anxiety Scale (MDAS). During and after the procedure, pain will be assessed using a Visual Analog Scale (VAS) from 0 to 100, and participants will rate their satisfaction using a Numerical Rating Scale (NRS) from 0 to 10.
The purpose of this research is to help orthodontists identify the method that makes braces removal less uncomfortable, more tolerable, and more satisfying for patients.
Detailed description
This clinical study aims to evaluate and compare the effectiveness and cost-effectiveness of TENS (Dental Pain Eraser) and high-frequency vibration (SureSmile® VPro™) in reducing discomfort during orthodontic bracket removal, improving patient satisfaction, and optimizing efficiency. The study includes a control group, and results are intended to provide evidence-based guidance for orthodontists to enhance the patient experience during debonding procedures.
Participants will be individuals who have completed fixed orthodontic treatment and are scheduled for bracket removal. Before the procedure, their baseline dental anxiety will be assessed. The assigned intervention will be applied either immediately before (TENS) or during (vibration) the bracket removal session. Participants' experiences of pain and satisfaction will be monitored throughout the procedure. Sex and baseline anxiety will be considered in the analysis to evaluate their influence on outcomes. A cost-effectiveness analysis will be performed to determine the most efficient method among the interventions.
The research will be conducted in a standardized clinical setting, adhering to established bracket removal protocols to ensure participant safety and minimize variability. The procedures will be performed by the same operator following consistent techniques.
This study is designed to generate practical insights into pain management during orthodontic debonding, focusing on participant comfort, satisfaction, and procedural efficiency, without compromising the quality of care. The findings may guide future clinical recommendations and improve patient-centered orthodontic practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three groups: TENS, high-frequency vibration, or control. Each participant will undergo a single session in which the assigned intervention is applied. The study is open-label, and all bracket removal procedures are performed by the same operator using standardized techniques to ensure consistency across groups. Baseline dental anxiety and sex will be recorded as covariates for analysis.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS) | Experimental | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Participants in this arm will receive transcutaneous electrical nerve stimulation (TENS) applied immediately before orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session. |
| High-Frequency Vibration (SureSmile® VPro™) | Experimental | Device: High-Frequency VibrationParticipants in this arm will receive high-frequency vibration applied during orthodontic bracket removal. Pain, satisfaction, and procedural efficiency will be assessed during a single session. |
| No Intervention | No intervention | –Participants in this arm will undergo standard orthodontic bracket removal without any additional device. Pain, satisfaction, and procedural efficiency will be assessed during a single session. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients scheduled for fixed orthodontic appliance removal.
- Permanent dentition present, including both anterior and posterior teeth.
- Age between 15-35 years.
- Ability to provide informed consent and comply with study procedures.
- General health adequate for routine orthodontic care.
Key exclusion criteria (6 listed)
- Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception.
- Teeth with extensive restorations or prostheses that prevent standard bracket debonding.
- Patients with known allergy or contraindication to TENS or vibration devices.
- Pregnant women.
- Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I.
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 |
|---|---|---|
| Transcutaneous Electrical Nerve Stimulation (TENS)TENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction. | Device | Transcutaneous Electrical Nerve Stimulation (TENS) |
| High-Frequency VibrationHigh-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction. | Device | High-Frequency Vibration (SureSmile® VPro™) |
Primary outcome
Pain During Orthodontic Debonding Measured by VAS
Time frame: During and immediately after debonding procedure
Pain during debonding will be measured immediately after the procedure using VAS 0-100 mm, where 0 = no pain and 100 = worst imaginable pain.
4 secondary outcomes
Baseline Anxiety
Time frame: Prior to the debonding procedure
Patient Satisfaction
Time frame: immediately post-procedure
Device Application Time
Time frame: Periprocedural (during the debonding session)
Cost-Effectiveness Analysis
Time frame: Periprocedural (during the debonding session) and at immediate post-procedure assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No. There is currently no definitive plan to share Individual Participant Data (IPD). However, IPD may be made available in the future if required by the journal in which the results are published, subject to ethical approval, institutional regulations, and obtaining appropriate patient consent. All shared data will be de-identified to protect participant confidentiality.
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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.
Ali M. Al-Attar, BDS, MSc, PhD principal investigator
University of Baghdad - College of Dentistry - 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 Transcutaneous Electrical Nerve Stimulation (TENS) and High-Frequency Vibration in people with Orthodontic Pain, run by University of Baghdad at 1 site in Iraq.
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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Apr 2026. 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 Iraq. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malak R. Alsaqqaf, B.D.S. (009647873431704, malak7alsaqqaf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Orthodontic Debonding Measured by VAS (time frame: During and immediately after debonding procedure). 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 20 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.