Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation (MOPs) in Adult.

August 30, 2025 updated by: Mohamed Ellamey, Al-Azhar University

Evaluation of the Hybrid Rapid Maxillary Expander Assisted With Micro-osteo Perforation (MOPs) in Adults: A Prospective Clinical Study

This study will be directed for Evaluation of the hybrid rapid maxillary expander assisted with Micro-osteo perforation (MOPs) in adults

Study Overview

Detailed Description

Transverse maxillary deficiencies are common orthodontic issues observed by professionals. It is estimated that 9.4% of adult orthodontic patients have a transverse maxillary deficiency in combination with a posterior cross bite. A normal transverse skeletal relationship between basal bones is fundamental to achieving a satisfactory and stable occlusion.

Therefore, to correct a maxillary transverse deficiency, palatal expanders are needed. Since Haas popularized this technique in the early 1960s, rapid palatal expanders are the most popular devices of choice, characterized by safety, predictability and efficiency.

The rapid process of activation reduces dental movements (side effects) thus enabling skeletal expansion. Surprisingly, only 30% of the expander opening seems to result in suture opening, whereas one-third reflects alveolar bending and another 30% dental movement.

During activations of traditional tooth-borne rapid palatal expansion devices, heavy transverse forces are generated in a short period of time, causing disruption of the inter sutural tissue thus producing midpalatal suture opening.

On many occasions, these expansion forces in-vivo are in the range of 75-120 N, measured at the level of the hyrax screw of the connecting stainless-steel wire arms at the buccal crowns. In vitro skeletal hybrid expanders, before plastic deformation, demonstrated expansion force values from 67 ± 13 N to 183 ± 48 N when tested on the mini-implant's reinforced bone-anchored wire arms .With these forces, the opening of the palatal suture in adolescents or young adults can be frequently unsuccessful.

Therefore, conventional expanders, under high loads, deform prematurely or create excessive molar tipping or mucosa soreness before

reaching midpalatal suture opening. If these expansion forces are not able to open the suture, surgically assisted rapid palatal expansion (SARPE) is suggested.

In addition, scientific papers do not provide information of the amount of force at the level of the midpalatal suture and the limit of plastic deformation. Solely anchored on orthodontic mini-implants (OMIs) and placed in the anterior-middle palate. These bone anchored expanders seem to improve the aforementioned drawbacks and provide greater expansion forces to facilitate midpalatal suture opening even in adult patients so as to avoid SARPE.

Major areas of resistance to hybrid rapid maxillary expansion are mid palatine suture and the pterygomaxillary articulation. With increasing the age, the interdigitation at sutures increases making the site more rigid. The concept of regional acceleratory phenomenon (RAP) can be used for such clinical challenges by using mild surgical trauma induced by Micro-osteo perforation (MOPs) to produce localized inflammation with the mid palatine suture being the only sight easily accessible for intervention, minimally invasive procedures like Micro-osteo perforation (MOPs) can be used to disrupt the mid palatine suture to make it more pliable to expansion forces.

Micro-osteo perforation (MOPs) along the mid palatal suture which will induce rapid acceleratory phenomenon which would accelerate the bone turnover and reduce the regional bone density leading to transient osteopenia and thus bringing out changes in the transverse dimension.

Cone beam computed tomography (CBCT) allows better imaging at low radiation dosages and presents a clear view of bony structures, tooth position, and type of palatal suture fusion with minimal image distortion. Although hybrid rapid maxillary expansion and minimally

invasive surgical techniques are often used in orthodontic clinical practice, only a few studies have been published in the literature on large groups of patients that present possible complications that may occur after practicing this method of orthodontic treatment.

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Naser City
      • Cairo, Naser City, Egypt, 4450113
        • Dental Medicine Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

randamly selected

Description

Inclusion Criteria:

  • An age range from 17-23 years.
  • Transverse maxillary deficiency.
  • Maxillary lingual Cross bite (unilateral or bilateral)
  • No history of previous orthodontic treatment.
  • Good oral and general health.
  • No systemic condition that could interfere with orthodontic treatment.

Exclusion Criteria:

  • Patient with craniofacial anomalies .
  • History of extraction of permanent teeth.
  • Previous orthodontic treatment.
  • Poor oral hygiene or periodontally compromised patient.
  • Previous history of bruxism, trauma or par functions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
intervention group
will receive a hybrid rapid maxillary expander assisted by Micro-osteo perforation (MOPs) in mid palatine suture
patients with constricted maxillary will applied for hybrid expansion and group of them will assisted by Micro-osteo perforation (MOPs)
control group
will receive a hybrid rapid maxillary expander without any thing
patients with constricted maxillary will applied for hybrid expansion and group of them will assisted by Micro-osteo perforation (MOPs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CBCT measurment
Time Frame: 3 weeks
amount of skeletal and dental expansion
3 weeks
suture opening
Time Frame: 3 weeks
amount of skeletal and dental expansion
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Raafat El ghetany Mohamed, professor, Al-Azhar University
  • Study Director: Ahmed Akram El-Awady, Lecturer, Al-Azhar University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

June 1, 2025

Study Completion (Actual)

August 20, 2025

Study Registration Dates

First Submitted

May 19, 2024

First Submitted That Met QC Criteria

June 18, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

August 30, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe