Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Accretions; Teeth
• Intervention / Treatment: Procedure: Micro-osteoperforation

Detailed Description

in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; the group underwent distalization, with no Micro-osteoperforation
Experimental: Single MOP; the group underwent one time Micro-osteoperforation procedure	Procedure: Micro-osteoperforation; flapless small punctures in the bone at direction of tooth movement to accelerate the movement.
Experimental: repeated MOP; the group underwent monthly Micro-osteoperforation procedure	Procedure: Micro-osteoperforation; flapless small punctures in the bone at direction of tooth movement to accelerate the movement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
decrease in length of maxillary first molars in mm.	the change in the lengths of roots of maxillary first molars in mm.	through study completion, an average 1 year
bone density	bone density around the first molar	through study completion, an average 1 year
pain perception questionnaire	evaluate the pain perception to the intervention	through study completion, an average 1 year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: yasser lotfy, professor, Mansoura University; Study Director: marwaa shamaa, ph.D, Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): November 1, 2021

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 9, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Deposits
• Other Study ID Numbers: A03120219

Drug and device information, study documents

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