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Clinical Trials/NCT05167708
NCT05167708CompletedNot Applicable

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

Mansoura University1 site in 1 country30 target enrollmentStarted: April 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
rate of maxillary first molar distal movement

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

single blinded, the assessor of the out comes did not participate in the study

Eligibility Criteria

Ages
16 Years to 20 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

control

No Intervention

the group underwent distalization, with no Micro-osteoperforation

Single MOP

Experimental

the group underwent one time Micro-osteoperforation procedure

Intervention: Micro-osteoperforation (Procedure)

repeated MOP

Experimental

the group underwent monthly Micro-osteoperforation procedure

Intervention: Micro-osteoperforation (Procedure)

Outcomes

Primary Outcomes

rate of maxillary first molar distal movement

Time Frame: through study completion, an average 1 year

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

Secondary Outcomes

  • pain perception questionnaire(through study completion, an average 1 year)
  • bone density(through study completion, an average 1 year)
  • decrease in length of maxillary first molars in mm.(through study completion, an average 1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alaa alkasaby

principal investigator

Mansoura University

Study Sites (1)

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