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

• Sponsor: Al-Azhar University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05960825
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Effects of; Movement of Teeth Assiste Wit MOPS and I-prf	Combination Product: injectable platelet rich fibrin versus microosteoperforation	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Assessment of Two Different Modalities of Maxillary Canine Retraction Assisted With Micro-osteoperforations Versus Injectable Platelet Rich Fibrin: A Comparative Clinical Study
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Mar 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 22 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AlAzhar university	Cairo		Egypt

Sponsors and Collaborators

• Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: farouk ahmed hussein, Principal Investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05960825
• Other Study ID Numbers: 857/140
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 27, 2023