NCT05429437

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

June 19, 2022

Last Update Submit

November 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of acceleration of canine retraction

    rate of canine retraction

    post interventional at 4 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

will include 9 patients

Biological: Injectable platelet rich fibrin .

Group II

ACTIVE COMPARATOR

will include 9 patients.

Biological: Injectable platelet rich fibrin .

Interventions

i-PRF with maxillary canine retraction that will be performed two times on intervention sides according to a standardized protocol.

Group I

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar university

Cairo, Egypt

Location

Related Publications (2)

  • Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Effect of injectable platelet-rich fibrin (i-PRF) in accelerating orthodontic tooth movement : A randomized split-mouth-controlled trial. J Orofac Orthop. 2021 Jul;82(4):268-277. doi: 10.1007/s00056-020-00275-x. Epub 2021 Jan 22.

    PMID: 33481053BACKGROUND
  • Erdur EA, Karakasli K, Oncu E, Ozturk B, Hakki S. Effect of injectable platelet-rich fibrin (i-PRF) on the rate of tooth movement. Angle Orthod. 2021 May 1;91(3):285-292. doi: 10.2319/060320-508.1.

    PMID: 33459765BACKGROUND

Study Officials

  • mohamed radwan, student

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 19, 2022

First Posted

June 23, 2022

Study Start

November 1, 2022

Primary Completion

March 1, 2023

Study Completion

August 1, 2023

Last Updated

November 14, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations