MARPE Effect With/Without MOP in Non-growing Patients

Not Applicable

Completed

• Conditions: Maxillary Transverse Deficiency
• Interventions: Procedure: MARPE without MOP; Procedure: MARPE with MOP

• Registration Number: NCT06502041
• Lead Sponsor: Mansoura University

Brief Summary

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

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 Timeline

• Study Start: 2022-09-05
• Primary Completion: 2024-01-03
• Status Verified: 2024-07
• Study Completion: 2024-07-03
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-13
• Last Update Submitted: 2024-07-13
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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.

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MARPE without MOP	MARPE without MOP	-
MARPE with MOP	MARPE with MOP	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansoura, Adakhlia, Egypt