Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With MOPs :A Comparative Clinical Study

Not Applicable

Active, not recruiting

• Conditions: Crowding of Anterior Maxillary Teeth
• Interventions: Procedure: microosteoperforations

• Registration Number: NCT05605652
• Lead Sponsor: Al-Azhar University

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.

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-31
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-04
• Last Update Posted: 2022-11-04
• Primary Completion: 2023-07-30
• Study Completion: 2023-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• 1. Class 1 skeletal pattern with normal facial proportions. 2. Patients with age range between 13 -19 years. 3. Moderate crowding of maxillary anterior region assessed by Little Irregularity Index (LII) that require treatment with fixed appliance using non extraction approach.

  2. 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. 3. Poor oral hygiene 4. Present or history of periodontal diseases. 5. Physical or mental disability. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	microosteoperforations	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.

Primary Outcome Measures

Name	Time	Method
• Overall time needed to complete leveling and alignment of maxillary anterior segment	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).	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	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.

Trial Locations

Locations (1)

Al Azhar University; 🇪🇬 Cairo, Nasr City, Egypt