Assesment of Two Different Modalities of Maxillary Canine Retraction Assisted With Injectable Platelet Rich Fibrin

November 9, 2022 updated by: mohamed radwan mohamed radwan el shamy, Al-Azhar University

Assesment of Two Different Modalities of Maxillary Canine Retraction Assisted With Injectable Platelet Rich Fibrin: A Prospective Clinical Study

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 1

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

15 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patient diagnosed to have an indication for non-extraction approach.
  • Poor oral hygiene or periodontally compromised patient.
  • Patient with craniofacial anomalies or previous history of trauma, bruxism or parafunctions.

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
Active Comparator: Group I
will include 9 patients
Biological: Injectable platelet rich fibrin .
i-PRF with maxillary canine retraction that will be performed two times on intervention sides according to a standardized protocol.
Biological: Injectable platelet rich fibrin .
i-PRF that will be performed four times on intervention sides according to a standardized protocol.
Active Comparator: Group II
will include 9 patients.
Biological: Injectable platelet rich fibrin .
i-PRF with maxillary canine retraction that will be performed two times on intervention sides according to a standardized protocol.
Biological: Injectable platelet rich fibrin .
i-PRF that will be performed four times on intervention sides according to a standardized protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of acceleration of canine retraction
Time Frame: post interventional at 4 months
rate of canine retraction
post interventional at 4 months

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Principal Investigator: mohamed radwan, student, 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 (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

March 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

June 19, 2022

First Submitted That Met QC Criteria

June 19, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 785/274

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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