NCT05604625

Brief Summary

The aim of this study is to compare the treatment results when treating Class II division 1 malocclusion using the Van Beek-Headgear Activator combination (vBHGA) appliance versus using the Andresen activator.

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 Dec 2022

Shorter than P25 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

First Submitted

Initial submission to the registry

October 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 30, 2022

Last Update Submit

October 30, 2022

Conditions

Class II Growth Modification

Outcome Measures

Primary Outcomes (1)

  • treating Class II division 1 malocclusion

    rate of mandibular and maxillary growth

    at 8 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

12 patients will receive Van-Beek activator and a headgear

Device: Van-Beek activator and a headgear

Group B

ACTIVE COMPARATOR

12 patients will receive Andresen activator

Device: Andresen activator

Interventions

Van-Beek activator and a headgearDEVICE

12 patients will receive Van-Beek activator and a headgear

Group A
Andresen activatorDEVICE

12 patients will receive Andresen activator.

Group B

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Class II division 1 indicated by ANB angle value ≥ 4º
  • Class II division 1 with overjet \> 5mm.
  • An age range between 8 and 13 years growing patient using cervical vertebral stage assessment (CVS).
  • No previous orthodontic treatment
  • No indications or symptoms of periodontal disease in the past or present, as determined by clinical and radiographic examination

You may not qualify if:

  • Missing teeth (excluding 3rd molars).
  • Craniofacial anomalies.
  • Medical condition or prescription medication that may affect growth.
  • Lack of compliance whenever documented in the charts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alazhar University

Cairo, Cairo Governorate, 11865, Egypt

Location

Related Publications (1)

  • Altenburger E, Ingervall B. The initial effects of the treatment of Class II, division 1 malocclusions with the van Beek activator compared with the effects of the Herren activator and an activator-headgear combination. Eur J Orthod. 1998 Aug;20(4):389-97. doi: 10.1093/ejo/20.4.389.

    PMID: 9753820BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 3, 2022

Study Start

December 15, 2022

Primary Completion

April 15, 2023

Study Completion

June 15, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)