Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

NCT05167708 | Completed

• 1 other identifier: A03120219
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.

Conditions

Accretions; Teeth

Outcome Measures

Primary Outcomes (1)

• rate of maxillary first molar distal movement

  evaluation of the whole rate of distal movement of the first molar

  through study completion, an average 1 year

Secondary Outcomes (3)

• decrease in length of maxillary first molars in mm.

  through study completion, an average 1 year

• bone density

  through study completion, an average 1 year

• pain perception questionnaire

  through study completion, an average 1 year

Study Arms (3)

control

NO INTERVENTION

the group underwent distalization, with no Micro-osteoperforation

Single MOP

EXPERIMENTAL

the group underwent one time Micro-osteoperforation procedure

Procedure: Micro-osteoperforation

repeated MOP

EXPERIMENTAL

the group underwent monthly Micro-osteoperforation procedure

Procedure: Micro-osteoperforation

Interventions

Micro-osteoperforation PROCEDURE

flapless small punctures in the bone at direction of tooth movement to accelerate the movement.

Single MOP; repeated MOP

Eligibility Criteria

• Age: 16 Years - 20 Years
• Gender Eligibility Details: sexual hormones could affect the study outcomes. aiming to minimize the factors that might cause bias of the results.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Space deficiency in the upper arch \> 5 mm, and \< 8 mm.
• Non-extraction lower arch.
• Full upper dentition up to the second molars.
• Third molar present in both sides, not yet erupted.

You may not qualify if:

• Systemic disease or syndrome.
• Evidence of root resorption.
• Poor oral hygiene.
• Previous orthodontic treatment
• Evidence of bone loss.
• Active periodontal disease.
• Pregnant females.
• Presence of oral habits

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

MeSH Terms

Conditions

Dental Deposits

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• yasser lotfy, professor

  Mansoura University

  STUDY CHAIR

• marwaa shamaa, ph.D

  Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blinded, the assessor of the out comes did not participate in the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: single-center, prospective, single blinded, with 3 parallel arms, randomized clinical trial that had a 1:1:1 allocation.

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 22, 2021
• Study Start: April 1, 2019
• Primary Completion: September 30, 2021
• Study Completion: November 1, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Locations

EG (1)