Clinical trial NCT05904587: Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance
Official title: Clinical Evaluation of the Effectiveness of Different Methods in Reducing Pain During Debonding of Orthodontic Fixed Appliance: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: pain and debonding
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-06-15
Enrollment: 128
Sex: ALL
Minimum age (years): 15
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain during debonding of conventional fixed orthodontic appliance
timeFrame: Intraprocedural
Secondary outcomes:
measure: the dentition segment with the highest pain scores
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: College of Dentistry, University of Baghdad
state: Bab Al-Muadham
Study officials:
affiliation: University of Baghdad
name: Ammar S Kadhum, Asst. Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.