NCT05904587

Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance

Clinical Evaluation of the Effectiveness of Different Methods in Reducing Pain During Debonding of Orthodontic Fixed Appliance: a Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: University of Baghdad · Academic / Other
• Sex: All
• Age: 15 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DEVICE	SureSmile® VPro™	the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure
OTHER	ortho technology, sports advantage, thermal forming soft EVA 3mm	the pain is recorded when the patient is biting on the EVA sheet during the debonding procedure
OTHER	cotton roll	the pain is recorded when the patient is biting on the cotton roll during the debonding procedure

Timeline

• Start date: 2023-03-19
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2023-06-15
• Last updated: 2023-06-15

Locations

1 site across 1 country: Iraq