Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors

Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors: A Comparative Clinical Trial

The aim of this prospective clinical study will be to compare the efficacy of micro osteoperforations versus injectable platelet-rich fibrin during orthodontic leveling and alignment of mandibular incisors.

Study Overview

• Status: Enrolling by invitation
• Conditions: Effect of Platelet Rich Fibrin Versus Microosteoperforation Compaed to Control Group Toothmovement
• Intervention / Treatment: Procedure: MOPs with leveling and alignment; Biological: iprf

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Alazhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. An age range from 15 to 25 years.
2. Participants who had a full set of permanent dentitions excluding the third molar.
3. Participants who had moderate crowding in the mandibular arch according to Little's irregularity index that necessitates non-extraction treatment in the mandibular arch.
4. Normal vertical facial proportions.
5. Participants who had good oral hygiene and no periodontal disease.
6. No systemic diseases or regular medication that could interfere and/or affect orthodontic teeth movement.
7. No evidence of craniofacial anomalies, such as clef lip and palate or previous history of trauma, bruxism, or parafunction.
8. No tooth size, shape, or root abnormalities visible on patient's radiographic records.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Any skeletal dysplasia or craniofacial malformation.
3. Retained primary or missing permanent teeth in the anterior area, and any kind of tooth/root shape anomaly or history of trauma affecting the incisors.
4. Systemic diseases or regular use of medications that could interfere with OTM.
5. Patients with root resorption, impacted canines, or dental anomalies.
6. Poor oral hygiene and uncontrolled periodontal diseases.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Microosteoperforation; MOPs with leveling and alignment that will be performed tow time according to standardized protocol	Procedure: MOPs with leveling and alignment; mop
Experimental: Injectable platelet rich fibrin; i-PRF with leveling and alignment that will be performed tow time according to standardized protocol	Biological: iprf; i-PRF with leveling and alignment
No Intervention: control group; leveling and alignment that will be performed without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of acceleration of leveling and alignment of mandibular incisors	rate of leveling and alignment	post interventional at 4months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Hasan Fares, Student, Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1001/3560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No