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MARPE Effect With/Without MOP in Non-growing Patients

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06502041
Enrollment
24
Registered
2024-07-15
Start date
2022-09-05
Completion date
2024-07-03
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Transverse Deficiency

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.

Interventions

PROCEDUREMARPE with MOP

mini-screw assisted rapid palatal expansion with micro-osteoperforation

PROCEDUREMARPE without MOP

mini-screw assisted rapid palatal expansion without micro-osteoperforation

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Eligibility

Sex/Gender
ALL
Age
20 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of days till diastema appearanceabout 1 month(days)
Amount of skeletal expansionabout 1 month(mm)
Pain experience during activation of expander by visual analogue scale ( VAS)about 1 monthsVAS: 0 ( no pain), 10 (unbearable pain)
Skeletal, Dental & Nasal readingsmeasured before treatment and after 6 month of treatmentfrom CBCT and scanned models measured in degrees & mm
Stability of correction of transverse deficiencyabout 6 monthsby measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026