NCT06020183

Brief Summary

This study aims to evaluate the Skeletal and Dento-alveolar expansion in adult patents using Four Mini-screws Supported Hyrax in compare with untreated control group.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

September 2, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 2, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2024

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

August 25, 2023

Last Update Submit

June 20, 2024

Conditions

Transverse Maxillary Deficiency

Keywords

maxillary expasnion

Outcome Measures

Primary Outcomes (1)

  • Skeletal maxillary expansion

    To compare the amount of skeletal expansion pre and post expansion

    5 months interval between pre and post-expansion

Secondary Outcomes (1)

  • Dento-alaveolar expansion

    5 months interval between pre and post-expansion

Study Arms (2)

Hybrid Hyrax

EXPERIMENTAL

these patents will be treated using Four mini-screws supported hyrax

Device: Hybrid hyrax

untreated control group

NO INTERVENTION

Ethically ,these patents will be treated at the end of the study using the same appliance used for the experimental group

Interventions

Hybrid hyraxDEVICE

these patents will be treated using Four mini-screws supported hybrid hyrax

Also known as: MARPE(miniscrews-assisted rapid palatal expander)
Hybrid Hyrax

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Unilateral or bilateral Dental posterior cross-bite
  • Skeletal Maxillary constriction
  • Male and female patients.
  • Chronological age (18-30 years).
  • Mid-palatal suture maturation (Grade C,D ) according to F Angileri classification
  • Good oral hygiene.
  • No craniofacial anomalies or syndromes

You may not qualify if:

  • Scissor-bite
  • Orthodontically-treated
  • functional cross bite due to premature occlusal contact
  • patients with a syndrome
  • cleft patients
  • Mid-palatal suture maturation(Grade A.B,E) according to F Angileri classification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, Giza Governorate, 23646375, Egypt

Location

Study Officials

  • Elzubair Osman

    Master Degree student ,Faculty of Dentistry, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Degree student ,Faculty of Dentistry ,Cairo university.

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

September 2, 2023

Primary Completion

July 2, 2024

Study Completion

August 6, 2024

Last Updated

June 21, 2024

Record last verified: 2024-06

Locations

EG(1)