MARPE Effect With/Without MOP in Non-growing Patients

NCT ID: NCT06502041

Last Updated: 2024-07-15

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-05

Study Completion Date

2024-07-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Maxillary Transverse Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Blinding of either patient or clinician is not possible. However, blinding was ensured during analyzing the data. All digital models and x-rays were coded and shuffled before they were evaluated and measured.

Study Groups

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MARPE with MOP

Group Type EXPERIMENTAL

MARPE with MOP

Intervention Type PROCEDURE

mini-screw assisted rapid palatal expansion with micro-osteoperforation

MARPE without MOP

Group Type ACTIVE_COMPARATOR

MARPE without MOP

Intervention Type PROCEDURE

mini-screw assisted rapid palatal expansion without micro-osteoperforation

Interventions

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MARPE with MOP

mini-screw assisted rapid palatal expansion with micro-osteoperforation

Intervention Type PROCEDURE

MARPE without MOP

mini-screw assisted rapid palatal expansion without micro-osteoperforation

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Motaz Elshehaby

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, Adakhlia, Egypt

Site Status

Countries

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Egypt

References

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Elshehaby M, Albelasy NF, Elbialy MA, Hafez AM, Abdelnaby YL. Evaluation of pain intensity and airway changes in non-growing patients treated by MARPE with and without micro-osteoperforation: a randomized clinical trial. BMC Oral Health. 2024 Nov 20;24(1):1411. doi: 10.1186/s12903-024-05196-4.

Reference Type DERIVED
PMID: 39563319 (View on PubMed)

Other Identifiers

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A05020822

Identifier Type: -

Identifier Source: org_study_id

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