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

NCT ID: NCT05604625

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2023-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Class II Growth Modification

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

12 patients will receive Van-Beek activator and a headgear

Group Type ACTIVE_COMPARATOR

Van-Beek activator and a headgear

Intervention Type DEVICE

12 patients will receive Van-Beek activator and a headgear

Group B

12 patients will receive Andresen activator

Group Type ACTIVE_COMPARATOR

Andresen activator

Intervention Type DEVICE

12 patients will receive Andresen activator.

Interventions

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Van-Beek activator and a headgear

12 patients will receive Van-Beek activator and a headgear

Intervention Type DEVICE

Andresen activator

12 patients will receive Andresen activator.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Essam Eldein Saad Hamed Shady

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alazhar University

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 9753820 (View on PubMed)

Other Identifiers

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851/2971

Identifier Type: -

Identifier Source: org_study_id

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