NCT05605652

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

November 4, 2022

Status Verified

October 1, 2022

Enrollment Period

2.2 years

First QC Date

October 31, 2022

Last Update Submit

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 INTERVENTION

leveling and alignment will be commenced without micro- osteoperforations

Experimental group

EXPERIMENTAL

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

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.

Also known as: MOPs
Experimental group

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Location

MeSH Terms

Interventions

morpholinopropane sulfonic acid

Study Officials

  • Raafat GH Mohamad, Asst Prof

    Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University

    STUDY CHAIR
  • Ahmed A El-Awady, Lecturer

    Department of orthodontics, Faculty of Dental Medicine (Boys-Cairo), Al-Azhar University

    STUDY DIRECTOR

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

Locations