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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Crowding of Anterior Maxillary Teeth
• Intervention / Treatment: Procedure: microosteoperforations

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Nasr City
    • Cairo, Nasr City, Egypt, 11651
      • Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

  4. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; leveling and alignment will be commenced without micro- osteoperforations
Experimental: 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.	Procedure: 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.; Other Names: MOPs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).	• Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).	2months-6months
• Overall time needed to complete leveling and alignment of maxillary anterior segment	• 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.	2months -6months
• Alignment improvement percentage	• 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.	2months -6months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Study Chair: Raafat GH Mohamad, Asst Prof, Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University; Study Director: Ahmed A El-Awady, Lecturer, Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 4, 2022

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 660/301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No