NCT07036822

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
19mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

1.2 years

First QC Date

June 17, 2025

Last Update Submit

June 24, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Skeletal and dental changes after skeletal anchored maxillary expander for constricted maxilla in adolescent and adult patients constricted maxilla in adolescent and adult patients

    changes in maxillary skeletal and dental arch width assessed by CBCT imaging before and after MARPE treatment.. evaluation includes skeletal expansion and transverse dental arch changes

    from baseline (T0) to post expansion (T1)approximately 3 months

Study Arms (2)

Adolescent group

EXPERIMENTAL
Device: Skeletal Anchored Maxillary Expander (MARPE)

Adult group

EXPERIMENTAL
Device: Skeletal Anchored Maxillary Expander (MARPE)

Interventions

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

Adolescent groupAdult group

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Saleh Anwar Saleh, Professor of orthodontics

    ALAzhar university ,faculty of dentistry

    STUDY DIRECTOR
  • Esmail Kamal Hewy, lecturer of orthodontics

    ALAzhar university ,faculty of dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samar Hassan Mahmoud Mohamed, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master's student, Faculty of Dental Medicine ,AL-Azhar University ,Assuit branch

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

June 27, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share