Back to resultsEthically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator
Primary Purpose
Class II Growth Modification
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Van-Beek activator and a headgear
Andresen activator
Sponsored by
About this trial
This is an interventional treatment trial for Class II Growth Modification
Eligibility Criteria
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.
Sites / Locations
- Alazhar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
12 patients will receive Van-Beek activator and a headgear
12 patients will receive Andresen activator
Outcomes
Primary Outcome Measures
treating Class II division 1 malocclusion
rate of mandibular and maxillary growth
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05604625
Brief Title
Ethically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator
Official Title
A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 15, 2022 (Anticipated)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
June 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Growth Modification
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
12 patients will receive Van-Beek activator and a headgear
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
12 patients will receive Andresen activator
Intervention Type
Device
Intervention Name(s)
Van-Beek activator and a headgear
Intervention Description
12 patients will receive Van-Beek activator and a headgear
Intervention Type
Device
Intervention Name(s)
Andresen activator
Intervention Description
12 patients will receive Andresen activator.
Primary Outcome Measure Information:
Title
treating Class II division 1 malocclusion
Description
rate of mandibular and maxillary growth
Time Frame
at 8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Alazhar University
City
Cairo
State/Province
القاهرة
ZIP/Postal Code
11865
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
9753820
Citation
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.
Results Reference
background
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Ethically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator
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