NCT07038902

Brief Summary

Comparative study between modified miniscrew-assisted rapid palatal expander and modified rapid palatal expander in molar distalization using CBCT.

Trial Health

75
On Track

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 Nov 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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 Progress25%
Nov 2025Dec 2027

First Submitted

Initial submission to the registry

June 18, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 26, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
1.1 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

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

June 18, 2025

Last Update Submit

December 23, 2025

Conditions

Keywords

Modified MARPEModified RPEMolar DistalizationCBCTOrthodontics

Outcome Measures

Primary Outcomes (1)

  • Amount of Molar Distalization Measured by CBCT

    Baseline (prior to initiation of molar distalization) At the end of the molar distalization phase (approximately 12 weeks post-treatment initiation).

Study Arms (2)

Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)

EXPERIMENTAL
Device: Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)

Modified Rapid Palatal Expander (RPE)

EXPERIMENTAL
Device: Group B: Modified Rapid Palatal Expander (RPE)

Interventions

A skeletal anchorage-supported with miniscrews inserted into the palate using a self-drilling technique.

Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)

A tooth-borne anchorage focusing on molar distalization .

Modified Rapid Palatal Expander (RPE)

Eligibility Criteria

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

You may qualify if:

  • Presence of permanent dentition
  • Skeletal Class I
  • Dental Class II molar relationship with moderate dental crowding
  • Crowding \>4mm
  • Good oral hygiene
  • Healthy periodontal condition

You may not qualify if:

  • Presence of craniofacial syndromes or cleft palate
  • History of previous orthodontic treatment
  • Poor oral hygiene or active periodontal disease
  • Contraindications to CBCT imaging (e.g., pregnancy, inability to remain still during the scan)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.

Asyut, Egypt

Location

MeSH Terms

Conditions

MalocclusionCrowding

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Study Officials

  • Mohammed Ahmed Salim, Professor

    Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Researcher, Al-Azhar University (Assiut branch)

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 26, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

December 24, 2025

Record last verified: 2025-12

Locations