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.
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.
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.
Parallel
Transcutaneous Electrical Nerve Stimulation (TENS)
DeviceTENS is applied immediately before orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
High-Frequency Vibration
DeviceHigh-frequency vibration is applied during orthodontic bracket removal in a single session to reduce pain and improve patient satisfaction.
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.
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).
Patient Satisfaction
Satisfaction will be assessed immediately post-procedure using Numeric Rating Scale (0-10) to evaluate comfort and overall acceptance of the method.
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.
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.
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