Methods That Reduce Pain During Debonding Fixed Orthodontic Appliance

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05904587
• Other study ID #: 780423
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2023
• Est. completion date: November 1, 2023

Study information

• Verified date: June 2023
• Source: University of Baghdad
• Contact: Alhasan I Ali, B.D.S.
• Phone: 7505959112
• Email: alhassan.ali22031[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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
• cotton roll
the pain is recorded when the patient is biting on the cotton roll during the debonding procedure

Locations

Country	Name	City	State
Iraq	College of Dentistry, University of Baghdad	Baghdad	Bab Al-Muadham

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

References & Publications (8)

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. — View Citation

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. — View 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.

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. — View 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.

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain during debonding of conventional fixed orthodontic appliance	pain will be estimated using 0-100 VAS (visual analogue scale) of each segment of the dentition during the debonding procedure	Intraprocedural
Secondary	the dentition segment with the highest pain scores	will be measured statistically	Intraprocedural