Clinical trial NCT06634017: Evaluation of Effect of Platelet-Rich Fibrin on Orthodontic Tooth Movement: a Split Mouth Randomised Controlled Trial
Official title: Evaluation of Effect of Platelet-Rich Fibrin on Orthodontic Tooth Movement: a Split Mouth Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Rate of Tooth Movement in Orthodontic Patients
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All routine history and medical records will be taken before commencing the treatment. The rate of orthodontic tooth movement and the root length of the canine will be measured using the calipers on cast model and the digital periapical X-Ray respectively using millimeter unit. All measurements will be recorded at the baseline (T0) followed by at the end of 8weeks (T1), before giving second dose of PRF, to assess single dose PRF outcomes and at end of 20 weeks (T2) to assess multiple dose PRF outcomes. Periapical x-rays to assess effect of single dose of PRF on root length will be taken at baseline (T0) just before injecting PRF and starting canine retraction and will be compared with the second periapical x-ray taken at the end of 8week (T1), just before injecting second dose of PRF.
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: : Distance of canine retraction in millimeters / month in different groups-control, single dose PRF and multiple doses of PRF.
timeFrame: 5 months
Secondary outcomes:
measure: Difference in root length of canine measured before and after canine retraction and compared amongst different groups
timeFrame: 5 month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow university of health sciences
state: Sindh
Study officials:
References: