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

NCT06634017 | Recruiting Phase 1

• 1 other identifier: FIFarooqui
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Rate of Tooth Movement in Orthodontic Patients

Outcome Measures

Primary Outcomes (1)

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

  5 months

Secondary Outcomes (1)

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

  5 month

Study Arms (2)

EXPERIMENTAL

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).

Biological: Platelet rich fibrin

CONTROL

PLACEBO COMPARATOR

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).

Biological: Platelet rich fibrin

Interventions

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).

CONTROL; EXPERIMENTAL

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow university of health sciences

Karachi, Sindh, 74200, Pakistan

RECRUITING

Central Study Contacts

Fahad Iqbal Farooqui, bds

CONTACT

021-111113847; fahad.iqbal@duhs.edu.pk

Hareem Sultan, Bds, Fcps, Morth

CONTACT

021-111113847; hareem.sultan@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: April 25, 2024
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

PA (1)