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

NCT ID: NCT05104190

Last Updated: 2021-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-06-24

Brief Summary

Purpose of this study was to evaluate different methods of controlling pain during debonding

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.

Conditions

Analgesia; Orthodontic Appliance Complication

Keywords

Orthodontic pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Stabilization of teeth during debonding using fingure pressure and elastic wafer

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Stabilization of teeth during debonding using fingure pressure and elastic wafer

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Armed Forces Institute of Dentistry, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

Kashif Iqbal

Dr. Kashif Iqbal (orthodontist)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zahra Khalid, BDS, FCPSII

Role: STUDY_CHAIR

AFID

Locations

Kashif Iqbal

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

Orthodontic pain

Identifier Type: -

Identifier Source: org_study_id