NCT05245929

Brief Summary

Comparing the efficacy and performance of two conventionally anchored distalizers after modifying them to be skeletally anchored. En masse distalization is attempted by consolidating the posterior maxillary segment "first premolar to second molar" as one unit.

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 Jan 2021

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

January 5, 2021

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

2.3 years

First QC Date

February 9, 2022

Last Update Submit

February 9, 2022

Conditions

Orthodontic Appliance Complication, Angle Class II Patients, Distalization

Outcome Measures

Primary Outcomes (1)

  • Amount of distalization

    difference in initial and final position of maxillary posterior segment

    6 months

Study Arms (2)

Skeletally anchored Distal Jet appliance

ACTIVE COMPARATOR
Device: Distalization

Skeletally anchored Hyrax screw distalizer

ACTIVE COMPARATOR
Device: Distalization

Interventions

DistalizationDEVICE

Distalizing the posterior maxillary segment

Skeletally anchored Distal Jet applianceSkeletally anchored Hyrax screw distalizer

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Full set of permanent teeth present, except for third molar
  • Bilateral Class II malocclusion with a mesial migration of maxillary posterior teeth
  • No systemic conditions interfering with treatment, as reported by patient
  • No previous Orthodontic treatment
  • Good Oral Hygiene
  • No use of any for of anti-inflammatory drugs

You may not qualify if:

  • Patient who required surgery to correct skeletal discrepancies
  • Patient with congenital dentoskeletal disorders
  • Missed or Mutilated teeth in Maxillary arch
  • Patients with poor oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University, faculty of dental medicine orthodontic clinic

Cairo, Nasr City, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

January 5, 2021

Primary Completion

May 1, 2023

Study Completion

January 1, 2024

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

EG(1)