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Clinical Trials/NCT05605652
NCT05605652
Active, not recruiting
Not Applicable

Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With Micro-osteoperforations:A Comparative Clinical Study.

Al-Azhar University1 site in 1 country28 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crowding of Anterior Maxillary Teeth
Sponsor
Al-Azhar University
Enrollment
28
Locations
1
Primary Endpoint
• Overall time needed to complete leveling and alignment of maxillary anterior segment
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

The aim of the study will be directed to evaluate the effect of micro-osteoperforation on orthodontic tooth movement during leveling and alignment of the maxillary anterior teeth.

Detailed Description

The current study will be conducted on a group of orthodontic patients attending the out patients clinic, Orthodontic Department, Faculty of Dental Medicine (Boys), AL- Azhar University, Cairo The patient will be randomly assigned into two equal groups: 1. Experimental group: Flapless micro-osteoperforations will be performed interproximally on the alveolar bone equidistant between upper right canine to upper left canine at every interdental alveolar bone except at the midline alveolar bone to prevent trauma to the soft tissue frenum before placing the initial leveling archwire. 2. Control group: leveling and alignment will be commenced without micro- osteoperforations.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
July 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omar Mohamed abd elsalam abo donia

Omar Abodonia

Al-Azhar University

Eligibility Criteria

Inclusion Criteria

  • Class 1 skeletal pattern with normal facial proportions.
  • Patients with age range between 13 -19 years.
  • Moderate crowding of maxillary anterior region assessed by Little Irregularity Index (LII) that require treatment with fixed appliance using non extraction approach.
  • All permanent teeth erupted (excluding 3rd molars).
  • No previous orthodontic treatment.
  • Good oral hygiene with no previous periodontal surgery.

Exclusion Criteria

  • Transverse and/or vertical skeletal dysplasia or craniofacial malformation.
  • Retained primary or missing permanent teeth in the maxillary anterior area.
  • Poor oral hygiene
  • Present or history of periodontal diseases.
  • Physical or mental disability.
  • Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.

Outcomes

Primary Outcomes

• Overall time needed to complete leveling and alignment of maxillary anterior segment

Time Frame: 2months -6months

• Overall time needed to complete leveling and alignment of maxillary anterior segment was calculated by the number of days between day of inserting the 1st archwire and at the end of the leveling and alignment stage.

• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).

Time Frame: 2months-6months

• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).

• Alignment improvement percentage

Time Frame: 2months -6months

• Alignment improvement percentage was calculated by dividing the amount of change in the LII value at a specific time point (calculated by subtracting the LII value at T1, T2, or T3 from the LII value at T0) by LII value at T0.

Study Sites (1)

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