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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-25

Study Completion Date

2025-04-24

Brief Summary

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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

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Detailed Description

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Conditions

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Rate of Tooth Movement in Orthodontic Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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).

Group Type EXPERIMENTAL

Platelet rich fibrin

Intervention Type 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

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).

Group Type PLACEBO_COMPARATOR

Platelet rich fibrin

Intervention Type 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).

Interventions

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Platelet 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).

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes