A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Stability of correction of transverse deficiency
Study Overview
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 Design
- Study Type
- Interventional
- 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 Criteria
- Ages
- 20 Years to 25 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The age ranges from 20-25 years.
- •Post pubertal adolescent
- •Skeletal transverse deficiency with unilateral or bilateral cross-bite
- •Extraction is not indicated in the lower arch.
- •Upper permanent dentition is erupted up to the second molars.
- •Average facial vertical growth pattern.
- •Space deficiency in the upper arch is less than 8 mm
Exclusion Criteria
- •Diseases and medications those are likely to affect bone biology.
- •Evidence of root resorption.
- •Poor oral hygiene.
- •Previous orthodontic treatment.
- •Evidence of bone loss.
- •Active periodontal disease.
- •Craniofacial congenital anomalies, such as cleft lip and palate.
- •Pregnant females.
- •Presence of oral habits.
Outcomes
Primary Outcomes
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
Pain experience during activation of expander by visual analogue scale ( VAS)
Time Frame: about 1 months
VAS: 0 ( no pain), 10 (unbearable pain)
Number of days till diastema appearance
Time Frame: about 1 month
(days)
Amount of skeletal expansion
Time Frame: about 1 month
(mm)
Skeletal, Dental & Nasal readings
Time Frame: measured before treatment and after 6 month of treatment
from CBCT and scanned models measured in degrees \& mm
Secondary Outcomes
No secondary outcomes reported
Investigators
Motaz Elshehaby
principal investigator
Mansoura University