Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance

Not Applicable

Recruiting

• Conditions: Pain
• Interventions: Device: SureSmile® VPro™; Other: cotton roll; Other: ortho technology, sports advantage, thermal forming soft EVA 3mm

• Registration Number: NCT05904587
• Lead Sponsor: University of Baghdad

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of four different methods (including the control group) in reducing pain during debonding of fixed orthodontic appliances in participants requiring the removal of their fixed orthodontic appliance.

The main question it aims to answer is which method (biting on a cotton roll, biting on a soft thermoplastic elastomeric sheet, and the use of low-level vibration in reducing pain during the debonding procedure) is most effective in reducing the patients' pain during debonding of conventional orthodontic fixed appliances.

Participants will be asked to give their pain score on a scale of 0 to 100 VAS (visual analogue scale) for every region of the dentition.

the researcher then will compare different scores of different methods to find the most effective method in reducing pain.

Detailed Description

After signing the consent form, the patient will be tested using General Anxiety Disorder 7 (GAD-7) to reduce the effect of general anxiety on pain scores. GAD consists of 7 statements designed to measure anxiety. This will aid in identifying individuals who have severe anxiety disorder and exclude them from the study to ensure more accurate results.

Four debonding methods will be used in this study; Routine mechanical debonding with debonding plier with an open mouth, which will be used as control, and three other interventions to manage pain including biting on a cotton roll, biting on an elastomeric wafer, and using vibration. All of the procedures will be done with the archwire in situ and with minimal torsional force on the bracket.

For the control group, the debonding will be done with an open-mouth technique without any support applied to the teeth. The cotton roll method will be done by asking the patient to bite on the cotton roll firmly but not excessively during the debonding procedure.

As for the elastomeric wafer group the patient will bite on the wafer firmly during the debonding procedure, in a similar fashion the patient will bite on the mouthpiece of the VPro vibration device.

Pain will be estimated by using 100mm VAS and recording the results for each sextant, accompanied by the GAD-7 results and the patient's age and gender.

Study Timeline

• Study Start: 2023-03-19
• Status Verified: 2023-06
• Study First Submitted: 2023-06-04
• Study First Submitted QC: 2023-06-12
• Last Update Submitted: 2023-06-12
• Study First Posted: 2023-06-15
• Last Update Posted: 2023-06-15
• Primary Completion: 2023-10-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Patients between 15-30 years of age who could understand, assess, and answer the questionnaires.
2. No history of taking medicine periodically or in the last 24 hours (e.g., painkillers, corticosteroids, and anti-flu drugs).
3. No debonded brackets prior to debonding procedure.
4. No missing teeth except extracted premolar.
5. Undergoing upper and lower fixed orthodontic treatment with 0.022-inch metal brackets.
6. Finishing arch wires present for at least two months.
7. No craniofacial deformities that would affect the dentoalveolar bone quality (e.g., cleft lip and palate) .

Exclusion Criteria

1. History of taking medicine periodically or in the last 24 h (e.g., analgesic, anti-inflammatory and anxiolytic).
2. GAD-7 score of ˃8.
3. Debonded brackets at the time of debonding.
4. Missing teeth except for extracted premolars.
5. Active periodontal problems (recession and mobility greater than Grade I),
6. Heavily restored or root canal treated tooth.
7. Craniofacial deformities that would affect dentoalveolar bone quality (e.g., cleft lip and palate).
8. Surgical treatment (including impacted tooth removal) and presence of mini-screws.
9. excessive gingival overgrowth.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
biting on the mouthpiece of vibrational device	SureSmile® VPro™	debonding of the bracket is done while the patient is biting on the mouthpiece of the vibrational device (SureSmile® VPro™) delivering vibrations to the dentition during the debonding procedure
biting on cotton roll	cotton roll	debonding of the bracket is done while the patient is biting on a cotton roll during the debonding procedure
biting on soft elastomeric wafer	ortho technology, sports advantage, thermal forming soft EVA 3mm	debonding of the bracket is done while the patient is biting on the preshaped soft elastomeric wafer (cut into a horseshoe shape) during the debonding procedure

Primary Outcome Measures

Name	Time	Method
pain during debonding of conventional fixed orthodontic appliance	Intraprocedural	pain will be estimated using 0-100 VAS (visual analogue scale) of each segment of the dentition during the debonding procedure

Secondary Outcome Measures

Name	Time	Method
the dentition segment with the highest pain scores	Intraprocedural	will be measured statistically

Trial Locations

Locations (1)

College of Dentistry, University of Baghdad; 🇮🇶 Baghdad, Bab Al-Muadham, Iraq