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

Sponsor

Armed Forces Institute of Dentistry, Pakistan (Other)

Overall Status

Completed

CT.gov ID

NCT05104190

Collaborator

(none)

148

Enrollment

Location

Arms

17.7

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Analgesia Orthodontic Appliance Complication	Other: Stabilization of teeth during debonding using fingure pressure and elastic wafer	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jun 27, 2019

Actual Study Completion Date :

Jun 24, 2020

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

Measurement of pain [Immediatey after debonding]
Using visual analogue scale pain was measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kashif Iqbal	Karachi	Sindh	Pakistan	75080

Sponsors and Collaborators

Armed Forces Institute of Dentistry, Pakistan

Investigators

Study Chair: Zahra Khalid, BDS, FCPSII, AFID

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kashif Iqbal, Dr. Kashif Iqbal (orthodontist), Armed Forces Institute of Dentistry, Pakistan

ClinicalTrials.gov Identifier:

NCT05104190

Other Study ID Numbers:

Orthodontic pain

First Posted:

Nov 2, 2021

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Kashif Iqbal, Dr. Kashif Iqbal (orthodontist), Armed Forces Institute of Dentistry, Pakistan

Orthodontic pain

Study Results

No Results Posted as of Nov 2, 2021