NCT06130748

Brief Summary

The study aiming at evaluation of the Skeletal and Dento-alveolar expansion in adult patents using Two Mini-screws Supported Hyrax compared with untreated control group.

Trial Health

43
At Risk

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 Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

April 2, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2024

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

November 3, 2023

Last Update Submit

November 8, 2023

Conditions

Transverse Maxillary Deficiency

Keywords

maxillary expansion

Outcome Measures

Primary Outcomes (1)

  • Skeletal maxillary expansion To compare the amount of skeletal expansion pre and post expansion

    To compare the amount of skeletal expansion using linear and angular measurements and the expansion pattern of mid-palatal suture extracted from cone beam computed tomography pre and post expansion

    the outcome will be assessed five months post-expansion

Secondary Outcomes (1)

  • Dento-alaveolar expansion

    the outcome will be assessed five months post-expansion

Study Arms (2)

Hybrid Hyrax

EXPERIMENTAL

Device: Hybrid hyrax these patents will be treated using Two mini-screws supported hybrid hyrax Other Names: • MARPE(miniscrews-assisted rapid palatal expander)

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 Two 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of dentistry, Cairo university

Cairo, Giza Governorate, 4240310, Egypt

Location

Study Officials

  • abdullah mo ali al-thalabi, Msc candidate

    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

November 3, 2023

First Posted

November 14, 2023

Study Start

April 2, 2023

Primary Completion

December 2, 2023

Study Completion

June 2, 2024

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

EG(1)