NCT05899530

Brief Summary

Cbct evaluation of dentoskeletal changes after expansion using Invisalign versus conventional expander

Trial Health

35
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 Jul 2023

Shorter than P25 for not_applicable

Status
unknown

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

May 25, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 22, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

June 13, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

May 25, 2023

Last Update Submit

June 11, 2023

Conditions

Expansion of Maxillary ArchMaxillary Hypoplasia

Keywords

ExpanderHyraxInvisalign

Outcome Measures

Primary Outcomes (1)

  • Linear amount of midpalatal Suture opening

    Apperance of Distema , calculate the amount of general space

    4 months

Study Arms (2)

Conventional expander

ACTIVE COMPARATOR

Expansion using conventional orthodontic expander(hyrax)

Device: Conventional expander

Invisalign

EXPERIMENTAL

Expansion with Invisalign appliance

Device: Invisalign

Interventions

InvisalignDEVICE

Expansion using Invisalign versus conventional expander

Also known as: Hyrax
Invisalign
Conventional expanderDEVICE

conventional expander

Conventional expander

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age (12-16)
  • Good oral hygiene
  • Constricted maxilla or moderate crowding

You may not qualify if:

  • Patient receive drugs
  • Periodontal diseas
  • Past Orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retrognathia

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesMandibular DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Saleh A Saleh, Professor

    Al-Azhar University

    STUDY DIRECTOR

  • Mohamad A Salem, Professor

    Al-Azhar University

    STUDY DIRECTOR

  • Mohsena A Abdarrazik, Lecturer

    Al-Azhar University

    STUDY DIRECTOR

Central Study Contacts

Amro S Ibrahim

CONTACT

+201002125687amrIbrahim.209@azhar.edu.eg

Mohsena A Abdarrazik

CONTACT

+201005839539mohsenaahmad.el.8.383@azhar.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Invisalign versus conventional expander
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Expansion of maxillary arch by 2 different techniques including conventional expander in one group compared with expansion with clear aligner.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AzharU

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 12, 2023

Study Start

July 22, 2023

Primary Completion

March 30, 2024

Study Completion

May 31, 2024

Last Updated

June 13, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share