Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforation on Root Resorption During Orthodontic Intrusion of Incisor Teeth

• Sponsor: Al-Azhar University (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05958498
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8
• Patients Per Site Per Month: 2.2

Study Details

Study Description

Brief Summary

Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth

Condition or Disease	Intervention/Treatment	Phase
Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors	Combination Product: injectable platelet rich fibrin and microosteoperforation	Phase 1

Detailed Description

Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth: A comparative clinical study

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforationon Root Resorption During Orthodontic Intrusion of Incisor Teeth: A Comparative Clinical Study
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group I who will receive intrusive arches after leveling and alignment assisted with i-PRF according to standardized protocol	Combination Product: injectable platelet rich fibrin and microosteoperforation; i-PRF which second product of blood versus mops which is surgical procedure
Active Comparator: Group II Will includes 9 patients who will receive intrusive utility arches after leveling and alignment assisted with (MOPs) according to standardized protocol.	Combination Product: injectable platelet rich fibrin and microosteoperforation; i-PRF which second product of blood versus mops which is surgical procedure

Outcome Measures

Primary Outcome Measures

1. to compare the effect of injectable platelets rich fibrin and micro-osteoperforations on root resorption during orthodontic intrusion of incisors. [post interventionalal at 6months]

   amount of root resorption

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 1. Patients with age range between 12-16 years. 2. Overbite > 40% indicated for maxillary intrusion. 3. Mild to moderate crowding of upper incisors. 4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.

Exclusion Criteria:

1. • Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly.

2. Patients with root resorption, impacted canines, or dental anomalies. 4. Poor oral hygiene 5. Present or history of periodontal diseases. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.

3. History of trauma affecting the maxillary incisors. 8. Endodontically treated upper anterior teeth.

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

• Dos Santos CCO, Mecenas P, de Castro Aragon MLS, Normando D. Effects of micro-osteoperforations performed with Propel system on tooth movement, pain/quality of life, anchorage loss, and root resorption: a systematic review and meta-analysis. Prog Orthod. 2020 Jul 27;21(1):27. doi: 10.1186/s40510-020-00326-4.
• Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.

• Responsible Party: farouk ahmed hussein, Principal Investigator, Al-Azhar University
• ClinicalTrials.gov Identifier: NCT05958498
• Other Study ID Numbers: 922/91
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 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
• Additional relevant MeSH terms: Root Resorption

Study Results

No Results Posted as of Jul 24, 2023