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Clinical Trials/NCT06634017
NCT06634017
Recruiting
Phase 1

Evaluation of Effect of Platelet-Rich Fibrin on Orthodontic Tooth Movement: a Split Mouth Randomised Controlled Trial

Dow University of Health Sciences1 site in 1 country15 target enrollmentApril 25, 2024

Overview

Phase
Phase 1
Intervention
Platelet rich fibrin
Conditions
Rate of Tooth Movement in Orthodontic Patients
Sponsor
Dow University of Health Sciences
Enrollment
15
Locations
1
Primary Endpoint
: Distance of canine retraction in millimeters / month in different groups-control, single dose PRF and multiple doses of PRF.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

it is a randomized control trial and aims at investigating the effects of PRF on rate of tooth movement and root length to be tested on larger sample size of pakistani population

Registry
clinicaltrials.gov
Start Date
April 25, 2024
End Date
April 24, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fahad Iqbal Farooqui

Lecturer

Dow University of Health Sciences

Eligibility Criteria

Inclusion Criteria

  • Patients who give written consent to participate in the research
  • Orthodontic patients with good oral hygiene
  • Patients with periodontal probing depths≤3 mm with no bone loss
  • Patients undergoing orthodontic treatment with fixed appliance and requiring upper first premolar extraction followed by canine retraction
  • Patients treated with canine retraction utilizing maximum anchorage in the maxillary arch from trans-palatal arch anchorage device
  • Patients with mild to moderate crowding in maxillary arch
  • Patients with no previous history of orthodontic treatment

Exclusion Criteria

  • patients who are smokers, health compromised (such as diabetics, with bone disorders, immunocompromised, known with blood dyscrasias) will be excluded from the trial. Patients with drug history of non-steroidal anti-inflammatory drugs, anti-inflammatory (in last 30 days), antibiotic therapy in last 3 months and those women who are pregnant will also be excluded.
  • Other exclusion criteria will be patients with hypodontia, impacted/ectopic canines, extracted first molars, and patients who may discontinue the trial with or without assigning any reasons and those not consenting to participate in the research.

Arms & Interventions

EXPERIMENTAL

Only the test side that will be intervened with i-PRF will be obtained from the upper liquid layer and will be placed in dental injectors using a 27 mm gauged needle. During the first application the amount of i-PRF will be standardized as 4 mL and injected through intra-ligamental into the disto-buccal and disto-palatal side of the canine tooth (2 mL for each side) and at the time of second intervention i.e 8th week form the baseline intramucosal injection will be administered equidistant from the maxillary canine and second premolar, 2ml on buccal side and 2ml on palatal side) after anesthetizing the region with local anesthesia (2% Lignocaine).

Intervention: Platelet rich fibrin

CONTROL

On control side saline was injected using a 27 mm gauged needle. During the first application the saline was injected through intra-ligamental into the disto-buccal and disto-palatal side of the canine tooth (2 mL for each side) and at the time of second intervention i.e 8th week form the baseline intramucosal injection will be administered equidistant from the maxillary canine and second premolar, 2ml on buccal side and 2ml on palatal side) after anesthetizing the region with local anesthesia (2% Lignocaine).

Intervention: Platelet rich fibrin

Outcomes

Primary Outcomes

: Distance of canine retraction in millimeters / month in different groups-control, single dose PRF and multiple doses of PRF.

Time Frame: 5 months

Secondary Outcomes

  • Difference in root length of canine measured before and after canine retraction and compared amongst different groups(5 month)

Study Sites (1)

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