NCT07075211

Brief Summary

a device is going to be placed in the palate to non-growing patients who are diagnosed to have a constricted maxillary arch and require an expansion of the maxillary arch in their treatment plan. the device is composed of two mini screws that will be placed in the palate which are connected to a hyrax with orthodontic bands on first maxillary molars. the activation of the device will be for 3 weeks 2 turns on the day of placement and 1 turn every day for 3 weeks. a CBCT x-ray will be taken before and after expansion to see the effect of MARPE on the mid-palatal suture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2025

Completed
Last Updated

July 20, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

June 15, 2025

Last Update Submit

July 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • CBCT analysis : the mid palatal suture opening will be assessed from the axial slice.

    CBCT analysis: the mid palatal suture opening will be measures in millimetres at three different sites ( first premolar , second premolar, first molar). the metric measure will be placed at the two ends of the mid palatal suture

    3 weeks in each participant

Study Arms (1)

participants who received MARPE

EXPERIMENTAL

participants who received MARPE

Device: MARPE (mini-screw assisted rapid palatal expansion)

Interventions

MARPE (mini-screw assisted rapid palatal expansion) with two min screws in post-pubertal patients

participants who received MARPE

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Transverse maxillary deficiency with or without crossbite; who requires maxillary expansion in their treatment plan as described by Tamburino et al.3
  • Age after 16.
  • Presence of first and second upper premolars and first upper molars.
  • No previous orthodontic treatment.
  • Good oral hygiene and healthy periodontal tissue.
  • No significant dentofacial anomalies, any bone defects, or systemic disease.
  • Not being pregnant.
  • All patients were signed a written consent after accepting the treatment plan.

You may not qualify if:

  • Patients under the age of 16 years.
  • Absence of first and second upper premolars and first upper molars.
  • Previous orthodontic treatment
  • Periodontal disease and poor oral hygiene
  • significant dentofacial anomalies, any bone defects, or systemic disease.
  • Pregnant
  • Those who did not consent to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansura University, Faculty of Dentistry

Al Mansurah, Al Dakhelia, 7650001, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
postgraduate orthodontic student

Study Record Dates

First Submitted

June 15, 2025

First Posted

July 20, 2025

Study Start

May 1, 2024

Primary Completion

May 1, 2025

Study Completion

June 1, 2025

Last Updated

July 20, 2025

Record last verified: 2025-07

Locations