NCT06498609

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

July 7, 2024

Last Update Submit

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

EXPERIMENTAL

MOPs with leveling and alignment that will be performed tow time according to standardized protocol

Procedure: MOPs with leveling and alignment

Injectable platelet rich fibrin

EXPERIMENTAL

i-PRF with leveling and alignment that will be performed tow time according to standardized protocol

Biological: iprf

control group

NO INTERVENTION

leveling and alignment that will be performed without any intervention

Interventions

iprfBIOLOGICAL

i-PRF with leveling and alignment

Injectable platelet rich fibrin

mop

Microosteoperforation

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Interventions

morpholinopropane sulfonic acid

Study Officials

  • Hasan Fares, Student

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

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

Locations