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Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

NCT ID: NCT05167708

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-11-01

Brief Summary

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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

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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.

Conditions

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Accretions; Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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control

the group underwent distalization, with no Micro-osteoperforation

Group Type NO_INTERVENTION

No interventions assigned to this group

Single MOP

the group underwent one time Micro-osteoperforation procedure

Group Type EXPERIMENTAL

Micro-osteoperforation

Intervention Type PROCEDURE

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

repeated MOP

the group underwent monthly Micro-osteoperforation procedure

Group Type EXPERIMENTAL

Micro-osteoperforation

Intervention Type PROCEDURE

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

Interventions

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Micro-osteoperforation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Alaa alkasaby

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yasser lotfy, professor

Role: STUDY_CHAIR

Mansoura University

marwaa shamaa, ph.D

Role: STUDY_DIRECTOR

Mansoura University

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A03120219

Identifier Type: -

Identifier Source: org_study_id