Evaluation of Leveling and Alignment of Maxillary Anterior Teeth Assisted With MOPs :A Comparative Clinical Study
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
June 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 31, 2022
CompletedFirst Posted
Study publicly available on registry
November 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedNovember 4, 2022
October 1, 2022
2.2 years
October 31, 2022
October 31, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
• 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
Study Arms (2)
Control group
NO INTERVENTIONleveling and alignment will be commenced without micro- osteoperforations
Experimental group
EXPERIMENTALFlapless 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- \. 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.
- \. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al Azhar University
Cairo, Nasr City, 11651, Egypt
MeSH Terms
Interventions
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Omar Abodonia
Study Record Dates
First Submitted
October 31, 2022
First Posted
November 4, 2022
Study Start
June 1, 2021
Primary Completion
July 30, 2023
Study Completion
July 30, 2023
Last Updated
November 4, 2022
Record last verified: 2022-10