Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets

October 25, 2021 updated by: Kashif Iqbal, Armed Forces Institute of Dentistry, Pakistan
Purpose of this study was to evaluate different methods of controlling pain during debonding

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients data was obtained from the Department of Orthodontics, Armed Forces Institute of Dentistry, Rawalpindi. One Hundred and ten patients were included in the study, which were divided into two groups, 55 patients in each group, based on method of controlling pain during debonding. To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 75080
        • Kashif Iqbal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Patients between 13-21 years of age who can understand, assess, and answer the questionnaires. 2) No missing teeth except extracted premolars 3) Undergoing upper and lower fixed orthodontic treatment with Roth prescription 0.022-inch metal brackets . 4) Finishing arch wires present for at least two months

Exclusion Criteria:

  1. The subjects with a previous history of facial or mandibular surgery or syndromes affecting the jaw or face .
  2. Patient with history of jaw sugeries.
  3. Patients with history of taking medicine periodically or in the last 24 hours (eg, painkillers, corticosteroids, and antiflu drugs),
  4. Patient with history of debonded brackets and replacement.
  5. Patient with history of tooth transplantation or microscrews placement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: plastic wafers group

In one arm/ group 1 (plastic wafers group), debonding was done by open mouth technique. All brackets were removed using same plier i.e. angled direct bracket remover. Figure pressure in the apical direction was applied concomitantly applied to stabilize each tooth. Loose cotton was used between thumb and tooth during debonding. Arch wires and ligatures were not removed during debonding.

Patient pain score during procedure was measured using visual analogue scale ranging from zero to one hundred (0-100) In
Other: Stabilization of teeth during debonding using fingure pressure and elastic wafer
To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.
Experimental: finger pressure group
In another arm/ group 2( finger pressure group) brackets were removed in the same way with the same debonding plier as in group 1 but soft acrylic sheets folded 4 times were placed between upper and lower dentition with the patient biting on this wafer. Wires and ligatures were left tied to brackets during debonding. After the procedure, patient was asked about pain using visual analogue scale.
Other: Stabilization of teeth during debonding using fingure pressure and elastic wafer
To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of pain
Time Frame: Immediatey after debonding
Using visual analogue scale pain was measured
Immediatey after debonding

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Armed Forces Institute of Dentistry, Pakistan

Investigators

  • Study Chair: Zahra Khalid, BDS, FCPSII, AFID

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

June 27, 2019

Study Completion (Actual)

June 24, 2020

Study Registration Dates

First Submitted

August 4, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 25, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Orthodontic pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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