NCT05433038

Brief Summary

study will be directed to evaluate two approaches of microosteoperforations during skeletally anchored maxillary expansion

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

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

May 20, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 22, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
Last Updated

June 27, 2022

Status Verified

June 1, 2022

Enrollment Period

1.9 years

First QC Date

June 22, 2022

Last Update Submit

June 22, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • skeletally transverse measurement

    using cone beam computed tomography

    from start of treatment until study completion an average of 1 year

  • dentolinear measurement

    using cone beam computed tomography

    from start of treatment until study completion an average of 1 year

  • dentoangular measurement

    using cone beam computed tomography

    from start of treatment until study completion an average of 1 year

Study Arms (2)

skeletal expander with microosteoperforation in mid palatine

ACTIVE COMPARATOR

group1.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture

Device: skeletally anchored maxillary expander

skeletal expander with microosteoperforation in mid palatine and buccally

ACTIVE COMPARATOR

group2.will include ten patients undergo skeletally anchored maxillary expander with microosteoperforation in mid palatine suture and buccally

Device: skeletally anchored maxillary expander

Interventions

used from day one and activated two times per day for two weeks

Also known as: mini implant assisted rapid palatine expander
skeletal expander with microosteoperforation in mid palatineskeletal expander with microosteoperforation in mid palatine and buccally

Eligibility Criteria

Age18 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients should satisfy the following criteria:-
  • An age range from 18-22.
  • Transverse maxillary deficiency.
  • Crossbite (unilateral or bilateral)
  • No previous orthodontic treatment.
  • Good oral and general health.
  • No systemic disease/ medication that could interfere with OTM.

You may not qualify if:

  • History of systemic and medical illness.
  • History of extraction of permanent teeth.
  • Previos orthodontic treatment.
  • Poor oral hygiene or periodontally compromised patient.
  • Patient with craniofacial anomaly or previous history of trauma,bruxism or parafunctions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar univesity

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BDS(2006),faculty of dental medicine suze canal university

Study Record Dates

First Submitted

June 22, 2022

First Posted

June 27, 2022

Study Start

May 20, 2022

Primary Completion

April 20, 2024

Study Completion

November 1, 2024

Last Updated

June 27, 2022

Record last verified: 2022-06

Locations