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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05104190
Other study ID # Orthodontic pain
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date June 24, 2020

Study information

Verified date October 2021
Source Armed Forces Institute of Dentistry, Pakistan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date June 24, 2020
Est. primary completion date June 27, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years to 21 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Analgesia
  • Orthodontic Appliance Complication

Intervention

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.

Locations

Country Name City State
Pakistan Kashif Iqbal Karachi Sindh

Sponsors (1)

Lead Sponsor Collaborator
Armed Forces Institute of Dentistry, Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of pain Using visual analogue scale pain was measured Immediatey after debonding
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