Assessment of the Efficacy of Microosteoperforations Versus Injectable Platelet-rich Fibrin During Orthodontic Leveling and Alignment of Mandibular Incisors
1 other identifier
interventional
24
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2024
CompletedFirst Posted
Study publicly available on registry
July 12, 2024
CompletedStudy Start
First participant enrolled
August 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJuly 12, 2024
May 1, 2024
3 months
July 7, 2024
July 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of acceleration of leveling and alignment of mandibular incisors
rate of leveling and alignment
post interventional at 4months
Study Arms (3)
Microosteoperforation
EXPERIMENTALMOPs with leveling and alignment that will be performed tow time according to standardized protocol
Injectable platelet rich fibrin
EXPERIMENTALi-PRF with leveling and alignment that will be performed tow time according to standardized protocol
control group
NO INTERVENTIONleveling and alignment that will be performed without any intervention
Interventions
Eligibility Criteria
You may qualify if:
- An age range from 15 to 25 years.
- Participants who had a full set of permanent dentitions excluding the third molar.
- Participants who had moderate crowding in the mandibular arch according to Little's irregularity index that necessitates non-extraction treatment in the mandibular arch.
- Normal vertical facial proportions.
- Participants who had good oral hygiene and no periodontal disease.
- No systemic diseases or regular medication that could interfere and/or affect orthodontic teeth movement.
- No evidence of craniofacial anomalies, such as clef lip and palate or previous history of trauma, bruxism, or parafunction.
- No tooth size, shape, or root abnormalities visible on patient's radiographic records.
You may not qualify if:
- Previous orthodontic treatment.
- Any skeletal dysplasia or craniofacial malformation.
- 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.
- Systemic diseases or regular use of medications that could interfere with OTM.
- Patients with root resorption, impacted canines, or dental anomalies.
- Poor oral hygiene and uncontrolled periodontal diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alazhar University
Cairo, Egypt
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Hasan Fares, Student
Al-Azhar University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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
July 7, 2024
First Posted
July 12, 2024
Study Start
August 1, 2024
Primary Completion
November 1, 2024
Study Completion
December 1, 2024
Last Updated
July 12, 2024
Record last verified: 2024-05