Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance
NCT ID: NCT05904587
Last Updated: 2023-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
128 participants
INTERVENTIONAL
2023-03-19
2023-11-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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open mouth debonding
debonding of the bracket is done while the mouth of the patient is open and without any support to the teeth during the debonding procedure
No interventions assigned to this group
biting on soft elastomeric wafer
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
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
biting on cotton roll
debonding of the bracket is done while the patient is biting on a cotton roll during the debonding procedure
cotton roll
the pain is recorded when the patient is biting on the cotton roll during the debonding procedure
biting on the mouthpiece of vibrational device
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
SureSmile® VPro™
the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure
Interventions
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SureSmile® VPro™
the pain is recorded when the patient is biting on the mouthpiece of the device during the debonding procedure
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
cotton roll
the pain is recorded when the patient is biting on the cotton roll during the debonding procedure
Eligibility Criteria
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Inclusion Criteria
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
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.
15 Years
30 Years
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Alhasan Ibraheem Ali
B.D.S.
Principal Investigators
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Ammar S Kadhum, Asst. Prof.
Role: STUDY_DIRECTOR
University of Baghdad
Locations
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College of Dentistry, University of Baghdad
Baghdad, Bab Al-Muadham, Iraq
Countries
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Central Contacts
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Facility Contacts
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References
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Almuzian M, Rizk MZ, Ulhaq A, Alharbi F, Alomari S, Mohammed H. Effectiveness of different debonding techniques and adjunctive methods on pain and discomfort perception during debonding fixed orthodontic appliances: a systematic review. Eur J Orthod. 2019 Sep 21;41(5):486-494. doi: 10.1093/ejo/cjz013.
Bavbek NC, Tuncer BB, Tortop T, Celik B. Efficacy of different methods to reduce pain during debonding of orthodontic brackets. Angle Orthod. 2016 Nov;86(6):917-924. doi: 10.2319/020116-88R.1. Epub 2016 May 12.
Celebi, F. (2021) Evaluation of the effects of cotton roll-biting on debonding pain: a split-mouth study. South European Journal of Orthodontics And Dentofacial Research, 8, 1-7.
Gupta SP, Rauniyar S, Prasad P, Pradhan PMS. A randomized controlled trial to evaluate the effectiveness of different methods on pain management during orthodontic debonding. Prog Orthod. 2022 Mar 1;23(1):7. doi: 10.1186/s40510-022-00401-y.
Jaypapal, J., Maheshwari, U. and Vijayalakshmi, V. (2020) Comparison of pain perception during debonding between conventional and vibratory therapy. Annals of the Romanian Society for Cell Biology, 24, 701-715.
Kilinc DD, Sayar G. Evaluation of pain perception during orthodontic debonding of metallic brackets with four different techniques. J Appl Oral Sci. 2019 Jan 7;27:e20180003. doi: 10.1590/1678-7757-2018-0003.
Pithon MM, Santos Fonseca Figueiredo D, Oliveira DD, Coqueiro Rda S. What is the best method for debonding metallic brackets from the patient's perspective? Prog Orthod. 2015;16:17. doi: 10.1186/s40510-015-0088-7. Epub 2015 Jun 17.
Williams OL, Bishara SE. Patient discomfort levels at the time of debonding: a pilot study. Am J Orthod Dentofacial Orthop. 1992 Apr;101(4):313-7. doi: 10.1016/S0889-5406(05)80324-5.
Musawi AI, Kadhum AS. Effectiveness of high-frequency vibration, cotton rolls and elastomeric wafers in alleviating debonding pain of orthodontic metal brackets: a randomized clinical trial. Sci Rep. 2024 Oct 24;14(1):25160. doi: 10.1038/s41598-024-75725-2.
Other Identifiers
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780423
Identifier Type: -
Identifier Source: org_study_id
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