Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin

July 22, 2023 updated by: farouk ahmed hussein, Al-Azhar University

Assessment of Two Different Modalities of Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin: A Comparative Clinical Study

The present clinical comparative study will be undertaken for assessment of two different modalities of maxillary canine retraction assisted with microosteoperforations versus injectable platelet rich fibrin.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Group I: will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.

▪ Group II: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Alazhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. An age ranges from 15-22 years.
  2. Severe crowding or protrusion requiring 1st premolars extractions followed by symmetrical canine retraction.
  3. All permanent teeth present, 3rd molars are excluded.
  4. Good oral and general health.
  5. No systemic disease/medication that could interfere with OTM.
  6. No previous orthodontic treatment.

Exclusion Criteria:

  1. Patient diagnosed to have an indication for non-extraction approach.
  2. Poor oral hygiene or periodontally compromised patient.
  3. Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.
  4. Previous orthodontic treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group MOPs
Group MOPs : will include 9 patients who willreceive MOPs with maxillary canine retraction that will be performed on intervention sides according to a standardized protocol.
Combination product: injectable platelet rich fibrin versus microosteoperforation
injectable platelet rich fibrin which is second product of blood versus microosteoperforation which is surgical procedure
No Intervention: Group IMOPS
other side in group which is control group
Experimental: Group i-PRF
group i-PRF: will include 9 patients receive i-PRF that will be performed on intervention sides according to a standardized protocol
Combination product: injectable platelet rich fibrin versus microosteoperforation
injectable platelet rich fibrin which is second product of blood versus microosteoperforation which is surgical procedure
No Intervention: group i-PRF2
other side in group which is control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation period and on every 28 days observation period according to standardized method
Time Frame: 4months

Direct clinical assessment of the amount of maxillary canine retraction i.e. amount of extraction space closure before and after four months observation and every 28 days period and on every 28 days observation period according to standardized method. 2. Study cast assessment:

• The amount of maxillary canine retraction on both sides will be measured immediately before starting canine retraction and at each observation interval by using a software for the scanned models according to standardized method
4months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

July 15, 2023

First Submitted That Met QC Criteria

July 22, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 857/140

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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