Clinical trial NCT05605652: Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With MOPs :A Comparative Clinical Study
Official title: Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With Micro-osteoperforations:A Comparative Clinical Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crowding of Anterior Maxillary Teeth
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-11-04
Enrollment: 28
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: • Alignment progress was evaluated on 3D digital model taken before inserting the 1st archwire and then at all subsequent visits using (LII).
timeFrame: 2months-6months
measure: • Overall time needed to complete leveling and alignment of maxillary anterior segment
timeFrame: 2months -6months
measure: • Alignment improvement percentage
timeFrame: 2months -6months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Nasr City
Study officials:
affiliation: Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University
name: Raafat GH Mohamad, Asst Prof
role: STUDY_CHAIR
affiliation: Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University
name: Ahmed A El-Awady, Lecturer
role: STUDY_DIRECTOR
References: