Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06634017

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

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Platelet rich fibrin

Biological

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).

Primary outcomes

  1. : 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

  1. Difference in root length of canine measured before and after canine retraction and compared amongst different groups

    Time frame: 5 month

Study contacts

Contact information is provided by the study sponsor or research team.

Fahad Iqbal Farooqui, bds

CONTACT

[email protected]

021-111113847 ext. 7020

Hareem Sultan, Bds, Fcps, Morth

CONTACT

[email protected]

021-111113847 ext. 7020

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 9, 2024
Registry last updated
Oct 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.