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

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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06634017
Enrollment
15
Registered
2024-10-09
Start date
2024-04-25
Completion date
2025-04-24
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rate of Tooth Movement in Orthodontic Patients

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

Interventions

BIOLOGICALPlatelet rich fibrin

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).

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

This trial will be a double-blind trial where the examiner and the patient both will be blind. Since the placebo and i-PRF will be in similar looking glass tubes the patient and the investigator/ examiner who is the orthodontist will not know which side of the maxilla has been intervened with i-PRF and which one with the placebo injection.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
: Distance of canine retraction in millimeters / month in different groups-control, single dose PRF and multiple doses of PRF.5 months

Secondary

MeasureTime frame
Difference in root length of canine measured before and after canine retraction and compared amongst different groups5 month

Countries

Pakistan

Contacts

Primary ContactFahad Iqbal Farooqui, bds
fahad.iqbal@duhs.edu.pk021-111113847
Backup ContactHareem Sultan, Bds, Fcps, Morth
hareem.sultan@duhs.edu.pk021-111113847

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026