MARPE Effect With/Without MOP in Non-growing Patients

July 13, 2024 updated by: Motaz Elshehaby, Mansoura University

A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients

This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Adakhlia
      • Mansoura, Adakhlia, Egypt
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. The age ranges from 20-25 years.
  2. Post pubertal adolescent
  3. Skeletal transverse deficiency with unilateral or bilateral cross-bite
  4. Extraction is not indicated in the lower arch.
  5. Upper permanent dentition is erupted up to the second molars.
  6. Average facial vertical growth pattern.
  7. Space deficiency in the upper arch is less than 8 mm

Exclusion Criteria:

  1. Diseases and medications those are likely to affect bone biology.
  2. Evidence of root resorption.
  3. Poor oral hygiene.
  4. Previous orthodontic treatment.
  5. Evidence of bone loss.
  6. Active periodontal disease.
  7. Craniofacial congenital anomalies, such as cleft lip and palate.

7. Pregnant females. 8. Presence of oral habits.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MARPE with MOP
Procedure: MARPE with MOP
mini-screw assisted rapid palatal expansion with micro-osteoperforation
Active Comparator: MARPE without MOP
Procedure: MARPE without MOP
mini-screw assisted rapid palatal expansion without micro-osteoperforation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of days till diastema appearance
Time Frame: about 1 month
(days)
about 1 month
Amount of skeletal expansion
Time Frame: about 1 month
(mm)
about 1 month
Pain experience during activation of expander by visual analogue scale ( VAS)
Time Frame: about 1 months
VAS: 0 ( no pain), 10 (unbearable pain)
about 1 months
Skeletal, Dental & Nasal readings
Time Frame: measured before treatment and after 6 month of treatment
from CBCT and scanned models measured in degrees & mm
measured before treatment and after 6 month of treatment
Stability of correction of transverse deficiency
Time Frame: about 6 months
by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research
about 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2022

Primary Completion (Actual)

January 3, 2024

Study Completion (Actual)

July 3, 2024

Study Registration Dates

First Submitted

July 8, 2024

First Submitted That Met QC Criteria

July 13, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 13, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • A05020822

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the published results

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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