Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration

N/ANot Yet RecruitingNCT07293975

University of Baghdad90 enrolled

Overview

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.

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 Type

Eligibility

Sex: ALLMin age: 15 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients scheduled for fixed orthodontic appliance removal. 2. Permanent dentition present, including both anterior and posterior teeth. 3. Age between 15-35 years. 4. Ability to provide informed consent and comply with study procedures. 5. General health adequate for routine orthodontic care. 6. No history of regular or recent medication intake within the preceding 24 hours, including painkillers, corticosteroids, or anti-flu drugs. Exclusion Criteria: 1. Patients with craniofacial anomalies, systemic conditions affecting pain perception, or taking medications influencing nociception. 2. Teeth with extensive restorations or prostheses that prevent standard bracket debonding. 3. Patients with known allergy or contraindication to TENS or vibration devices. 4. Pregnant women. 5. Active periodontal disease, including gingival recession or tooth mobility exceeding Grade I. 6. Excessive gingival overgrowth that may impede debonding or influence study outcomes.

Outcomes

Primary Outcomes

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.

Time frame: During and immediately after debonding procedure

Secondary Outcomes

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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Periprocedural (during the debonding session) and at immediate post-procedure assessment.

Pain Control During Braces Removal Using Transcutaneous Electrical Nerve Stimulation and High-Frequency Vibration

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts