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

Primary Purpose

Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors

Status
Enrolling by invitation
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
injectable platelet rich fibrin and microosteoperforation
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors

Eligibility Criteria

15 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • AlAzhar university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

who will receive intrusive arches after leveling and alignment assisted with i-PRF according to standardized protocol

Will includes 9 patients who will receive intrusive utility arches after leveling and alignment assisted with (MOPs) according to standardized protocol.

Outcomes

Primary Outcome Measures

to compare the effect of injectable platelets rich fibrin and micro-osteoperforations on root resorption during orthodontic intrusion of incisors.
amount of root resorption

Secondary Outcome Measures

Full Information

First Posted
July 15, 2023
Last Updated
July 15, 2023
Sponsor
Al-Azhar University
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1. Study Identification

Unique Protocol Identification Number
NCT05958498
Brief Title
Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforation on Root Resorption During Orthodontic Intrusion of Incisor Teeth
Official Title
Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforationon Root Resorption During Orthodontic Intrusion of Incisor Teeth: A Comparative Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Compare the Effect of Injectable Platelets Rich Fibrin and Micro-osteoperforations on Root Resorption During Orthodontic Intrusion of Incisors

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
who will receive intrusive arches after leveling and alignment assisted with i-PRF according to standardized protocol
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Will includes 9 patients who will receive intrusive utility arches after leveling and alignment assisted with (MOPs) according to standardized protocol.
Intervention Type
Combination Product
Intervention Name(s)
injectable platelet rich fibrin and microosteoperforation
Intervention Description
i-PRF which second product of blood versus mops which is surgical procedure
Primary Outcome Measure Information:
Title
to compare the effect of injectable platelets rich fibrin and micro-osteoperforations on root resorption during orthodontic intrusion of incisors.
Description
amount of root resorption
Time Frame
post interventionalal at 6months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: - 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. 3. 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. 7. History of trauma affecting the maxillary incisors. 8. Endodontically treated upper anterior teeth.
Facility Information:
Facility Name
AlAzhar university
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33653326
Citation
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.
Results Reference
background
PubMed Identifier
32715352
Citation
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.
Results Reference
background

Learn more about this trial

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

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