MARPE Effect With/Without MOP in Non-growing Patients

NCT06502041 | Completed

• 1 other identifier: A05020822
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Transverse Deficiency

Outcome Measures

Primary Outcomes (5)

• Number of days till diastema appearance

  (days)

  about 1 month

• Amount of skeletal expansion

  (mm)

  about 1 month

• Pain experience during activation of expander by visual analogue scale ( VAS)

  VAS: 0 ( no pain), 10 (unbearable pain)

  about 1 months

• Skeletal, Dental & Nasal readings

  from CBCT and scanned models measured in degrees \& mm

  measured before treatment and after 6 month of treatment

• Stability of correction of transverse deficiency

  by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research

  about 6 months

Study Arms (2)

MARPE with MOP

EXPERIMENTAL

Procedure: MARPE with MOP

MARPE without MOP

ACTIVE COMPARATOR

Procedure: MARPE without MOP

Interventions

MARPE with MOP PROCEDURE

mini-screw assisted rapid palatal expansion with micro-osteoperforation

MARPE with MOP

MARPE without MOP PROCEDURE

mini-screw assisted rapid palatal expansion without micro-osteoperforation

MARPE without MOP

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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. 8. Presence of oral habits.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Adakhlia, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39563319 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: July 15, 2024
• Study Start: September 5, 2022
• Primary Completion: January 3, 2024
• Study Completion: July 3, 2024
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)