Ignite Creation Date:
2024-05-06 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05904587
Status:
RECRUITING
Last Update Posted:
2023-06-15
First Post:
2023-06-04
Brief Title:
Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance
Sponsor:
University of Baghdad
Organization:
University of Baghdad
Study Overview
Official Title:
Clinical Evaluation of the Effectiveness of Different Methods in Reducing Pain During Debonding of Orthodontic Fixed Appliance a Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients age and gender
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 patients age and gender
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None