Ethically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator

Sponsor

Al-Azhar University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05604625

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Class II Growth Modification	Device: Van-Beek activator and a headgear Device: Andresen activator	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator: A Randomized Clinical Trial

Anticipated Study Start Date :

Dec 15, 2022

Anticipated Primary Completion Date :

Apr 15, 2023

Anticipated Study Completion Date :

Jun 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A 12 patients will receive Van-Beek activator and a headgear	Device: Van-Beek activator and a headgear 12 patients will receive Van-Beek activator and a headgear
Active Comparator: Group B 12 patients will receive Andresen activator	Device: Andresen activator 12 patients will receive Andresen activator.

Arm

Intervention/Treatment

Active Comparator: Group A

12 patients will receive Van-Beek activator and a headgear

Device: Van-Beek activator and a headgear

12 patients will receive Van-Beek activator and a headgear

Active Comparator: Group B

12 patients will receive Andresen activator

Device: Andresen activator

12 patients will receive Andresen activator.

Outcome Measures

Primary Outcome Measures

treating Class II division 1 malocclusion [at 8 months]
rate of mandibular and maxillary growth

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 13 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alazhar University	Cairo	القاهرة	Egypt	11865

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Ahmed Essam Eldein Saad Hamed Shady, doctor, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05604625

Other Study ID Numbers:

851/2971

First Posted:

Nov 3, 2022

Last Update Posted:

Nov 3, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Malocclusion

Malocclusion, Angle Class II

Overbite

Study Results

No Results Posted as of Nov 3, 2022