Effects of Skeletal Anchored Maxillary Expander for Constricted Maxilla

NCT ID: NCT07036822

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-01

Brief Summary

The aim of study will be Evaluation of Effects of skeletal anchored maxillary expander for constricted maxilla with different patient's age

Detailed Description

Various factors contribute to transverse deficiencies in the dental arch, which can present in several ways, including posterior crossbite, a collapsed maxillary arch, discrepancies in transverse dental arch, and cleft palate. Several devices and orthopedic approaches have been developed to address transverse maxillary constriction, which can be either surgical or non-surgical, and these devices may be either fixed or removable. Various types of anchorage can be utilized, such as tooth-borne anchorage with a hyrax or tooth-tissue-borne and bone-borne methods like mini-implant-assisted rapid palatal expander (MARPE). Rapid maxillary expansion (RME) is a frequently employed and dependable technique to rectify transverse maxillary deficiencies in prepubertal and adolescent individuals. RPE successfully treats both unilateral and bilateral buccal crossbites by expanding the maxilla by separating the midpalate suture. It works especially well for developing individuals with mixed dentition, but in older teenagers, it might cause side effects such buccal tilting of teeth and periodontal issues In post pubertal individuals (including young adults and adults), the use of rapid maxillary expansion (RME) techniques remains debated, as the median palatal suture is frequently matured and challenging to open clinically. As a result, these methods might lead to negative side effects, such as dentoalveolar compensation and adverse dental and periodontal outcomes in the affected teeth instead of genuine skeletal expansion.

Mini implant-assisted rapid maxillary expansion aims to achieve skeletal expansion of the palatal arch while minimizing the unwanted dental complications The Mini screw-assisted rapid palatal expansion, designed by Lee et al., functions as a tooth-bone-borne RPE-Hyrax device that is anchored in the palate with four Mini screws connected through helical loops that were soldered to the base of the expansion screw. These tiny screws were essential in allowing the midpalatal sutures to separate by applying the expansion force straight to the palate. MARPE is employed in both adolescents and adults as an alternative to surgically assisted rapid palatal expansion (SARPE). CBCT images showed an increase in skeletal dimensions in adult and adolescent patients treated with MARPE and a reduction in dental side effects. In recent years, Mini screw-assisted rapid palatal expansion (MARPE) has emerged as a highly effective method for achieving skeletal expansion of the maxilla in adolescents and adults, especially in cases where traditional rapid palatal expansion (RPE) may be limited due to increased suture interdigitation with age. MARPE enables orthopedic expansion without the need for surgical assistance in many cases The accuracy, adaptability, and efficiency of MARPE devices have significantly increased with the incorporation of 3D printing technology. Cone-beam computed tomography (CBCT) data and digital intraoral scans are used to construct 3D-printed MARPE appliances, enabling patient-specific designs that maximize comfort, fit, and biomechanical efficacy. Mini screw placement accuracy, better appliance adaptation to palate anatomy, and less chairside time are all made possible by the digital workflow.

The present trend in orthodontics toward individualized and technologically advanced treatment options is best illustrated by the combination of MARPE and 3D printing. By providing a more pleasant and effective treatment mode, this innovation not only improves clinical outcomes but also the patient experiences

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Conditions

Maxillary Expansion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adolescent group

Group Type: EXPERIMENTAL

Skeletal Anchored Maxillary Expander (MARPE)

Intervention Type: DEVICE

Mini implant assisted rapid maxillary expander (MARPE) used for skeletal maxillary expansion in adolescent and adult patients

Adult group

Group Type: EXPERIMENTAL

Skeletal Anchored Maxillary Expander (MARPE)

Intervention Type: DEVICE

Mini implant assisted rapid maxillary expander (MARPE) used for skeletal maxillary expansion in adolescent and adult patients

Interventions

Skeletal Anchored Maxillary Expander (MARPE)

Mini implant assisted rapid maxillary expander (MARPE) used for skeletal maxillary expansion in adolescent and adult patients

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Skeletal maxillary transverse deficiency.
• Unilateral or bilateral posterior crossbite. .Patient maintains good oral hygiene and overall health.
• Patient with no previous orthodontic treatment.
• No systemic disease that may affect bone quality or interfere with orthodontic treatment.
• Adolescent and adult patien

Exclusion Criteria

• Craniofacial congenital disorders, including cleft lip and palate.
• History of periodontal disease

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samar Hassan Mahmoud Mohamed

OTHER

Sponsor Role: lead

Responsible Party

Samar Hassan Mahmoud Mohamed

Master's student, Faculty of Dental Medicine ,AL-Azhar University ,Assuit branch

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Saleh Anwar Saleh, Professor of orthodontics

Role: STUDY_DIRECTOR

ALAzhar university ,faculty of dentistry

Esmail Kamal Hewy, lecturer of orthodontics

Role: PRINCIPAL_INVESTIGATOR

ALAzhar university ,faculty of dentistry

Central Contacts

Samar Hassan Mahmoud Mohamed, BDS

Role: CONTACT

samarhassan1578@gmail.com

01271677891

Other Identifiers

Skeletal maxillary expansion

Identifier Type: -

Identifier Source: org_study_id