Class II Growth ModificationNCT05604625
Ethically Accepted With Code 851/2971 A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator
A study testing Van-Beek activator and a headgear and Andresen activator in people with Class II Growth Modification, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Growth Modification
- What is being tested?
- Van-Beek activator and a headgear and Andresen activator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Missing teeth (excluding 3rd molars).
- Craniofacial anomalies.
- Medical condition or prescription medication that may affect growth.
- Lack of compliance whenever documented in the charts.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator: A Randomized Clinical Trial
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.
- Conditions
- Class II Growth Modification
- Being tested
- Van-Beek activator and a headgear, Andresen activator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Van-Beek activator and a headgearDevice
12 patients will receive Van-Beek activator and a headgear
Andresen activatorDevice
12 patients will receive Andresen activator.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 12 patients will receive Van-Beek activator and a headgear Receives: Device: Van-Beek activator and a headgear |
| Group B | Active comparator | 12 patients will receive Andresen activator Receives: Device: Andresen activator |
What is being measured
The primary outcome is the main question the study is designed to answer.
treating Class II division 1 malocclusion
rate of mandibular and maxillary growth
Measured: at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start15 Dec 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Class II Growth ModificationStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Essam Eldein Saad Hamed Shady, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604625
- Sponsor's protocol ID
- 851/2971
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 9753820
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Class Ⅱ Malocclusion Treatment Using Van Beek-headgear Activator Versus Andresen Activator: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05604625
- Acronym / sponsor ID
- 851/2971
- Conditions
- Class II Growth Modification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Van-Beek activator and a headgear12 patients will receive Van-Beek activator and a headgear |
| Group B | Active comparator | Device: Andresen activator12 patients will receive Andresen activator |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Missing teeth (excluding 3rd molars).
- Craniofacial anomalies.
- Medical condition or prescription medication that may affect growth.
- Lack of compliance whenever documented in the charts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Van-Beek activator and a headgear12 patients will receive Van-Beek activator and a headgear | Device | Group A |
| Andresen activator12 patients will receive Andresen activator. | Device | Group B |
Primary outcome
treating Class II division 1 malocclusion
Time frame: at 8 months
rate of mandibular and maxillary growth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 9753820Altenburger 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.
- Individual participant dataSharing planned: Yes
Related trials for Class II Growth Modification
Not yet recruiting
The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
CLASS II DIVISION 1 MALOCCLUSION, Class II Malocclusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Van-Beek activator and a headgear and Andresen activator in people with Class II Growth Modification, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treating Class II division 1 malocclusion (time frame: at 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604625, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 2 Nov 2026.