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Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

Primary Purpose

Accretions; Teeth

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Micro-osteoperforation

About this trial

This is an interventional treatment trial for Accretions; Teeth

Eligibility Criteria

16 Years - 20 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

control

Single MOP

repeated MOP

Arm Description

the group underwent distalization, with no Micro-osteoperforation

the group underwent one time Micro-osteoperforation procedure

the group underwent monthly Micro-osteoperforation procedure

Outcomes

Primary Outcome Measures

rate of maxillary first molar distal movement

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

Secondary Outcome Measures

decrease in length of maxillary first molars in mm.

the change in the lengths of roots of maxillary first molars in mm.

bone density

bone density around the first molar

pain perception questionnaire

evaluate the pain perception to the intervention

Full Information

NCT ID

NCT05167708

First Posted

November 30, 2021

Last Updated

December 9, 2021

Sponsor

Mansoura University

1. Study Identification

Unique Protocol Identification Number

NCT05167708

Brief Title

Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

April 1, 2019 (Actual)

Primary Completion Date

September 30, 2021 (Actual)

Study Completion Date

November 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Accretions; Teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

the group underwent distalization, with no Micro-osteoperforation

Arm Title

Single MOP

Arm Type

Experimental

Arm Description

the group underwent one time Micro-osteoperforation procedure

Arm Title

repeated MOP

Arm Type

Experimental

Arm Description

the group underwent monthly Micro-osteoperforation procedure

Intervention Type

Procedure

Intervention Name(s)

Micro-osteoperforation

Intervention Description

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

Primary Outcome Measure Information:

Title

rate of maxillary first molar distal movement

Description

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

Time Frame

through study completion, an average 1 year

Secondary Outcome Measure Information:

Title

decrease in length of maxillary first molars in mm.

Description

the change in the lengths of roots of maxillary first molars in mm.

Time Frame

through study completion, an average 1 year

Title

bone density

Description

bone density around the first molar

Time Frame

through study completion, an average 1 year

Title

pain perception questionnaire

Description

evaluate the pain perception to the intervention

Time Frame

through study completion, an average 1 year

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

sexual hormones could affect the study outcomes. aiming to minimize the factors that might cause bias of the results.

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yasser lotfy, professor

Organizational Affiliation

Mansoura University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

marwaa shamaa, ph.D

Organizational Affiliation

Mansoura University

Official's Role

Study Director

Facility Information:

Facility Name

Mansoura University

City

Mansoura

State/Province

Dakahlia

ZIP/Postal Code

35516

Country

Egypt

12. IPD Sharing Statement

Learn more about this trial

Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

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