Class II Division 1 MalocclusionNCT00957489
A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion
A study testing Dynamax appliance and Twin-block appliance in people with Class II Division 1 Malocclusion, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have different effects with regards to treatment duration, the quality of dento-occlusal outcome, skeletal and soft tissue profile, patient discomfort and gingival health. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Dynamax appliance and Twin-block appliance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2007to Sep 2008
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients with a Class II malocclusion as defined by British Standards Institute classification.
- Overjet greater than 6mm
- Aged 10-14 years
- Clinical examination indicates a functional appliance is not contraindicated
Who cannot join
- Orthognathic treatment is required or there is a strong indication it will be required in the future
- Possession of a craniofacial anomaly
- Previous orthodontic treatment and/or premolar extraction
- Hypodontia of more than one teeth in any quadrant excluding third molars
- Inadequate oral hygiene
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Chesterfield Royal Hospital
Chesterfield
Derby Royak Hospital NHS Trust
Derby
About this study
Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have different effects with regards to treatment duration, the quality of dento-occlusal outcome, skeletal and soft tissue profile, patient discomfort and gingival health.
Read the detailed description
The Dynamax appliance is a relatively new appliance for the treatment of Class II malocclusion and was introduced in 2003. The appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. Furthermore, the Dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. There has been limited research into this appliance and only one trial has been carried out. In this study the effects of the Dynamax were compared with the Twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. For example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. This raises the question about the efficiency of the Dynamax appliance and whether or not they are effective in a 'real' world setting.
The aim of this study is to compare the effectiveness of the Dynamax appliance and the Twin-block appliance for the treatment of Class II Division 1 malocclusion.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Dynamax appliance, Twin-block appliance
- Keywords
- Orthodontic treatment of Class II division 1 malocclusion
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamax applianceOther
Twin-block applianceOther
| Study group | Role | What they receive |
|---|---|---|
| Functional appliance-Dynamax | Experimental | Not described Receives: Other: Dynamax appliance |
| Functional appliance- twin block | Other | Conventional treatment Receives: Other: Twin-block appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of treatment with functional appliance
Measured: 9 months
Overjet measurement
Measured: 9 months
Secondary outcomes (1)
Harms Breakages Number of treatment visits Total treatment time Quality of occlusal result (PAR Index) Restricted cephalometric (radiograph) analysis Patient perception questionnaire at six months into treatment
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: Study stopped due to increased harm and slow progress in the intervention group.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Principal investigator, Badri Thiruvenkatachari, University of Manchester
- Investigators
- Kevin O'Brien, BDS, MSc, FDSRCS, DORth, PhD, Principal investigator, Prof of Orthodontics/ Associate Dean Teaching and Learning, University of ManchesterJonathan Sandler, BDS, MSc, FDSRCS, MOrth RCS, Principal investigator, Consultant Orthodontist, Chesterfield NHS TrustAlison Murray, BDS, MSc, FDSRCS, MORth RCS, Principal investigator, Consultant Orthodontist, Derby NHS TrustBadri ' Thiruvenkatachari, BDS, MDS, MOrth RCS, PhD, Study director, Clinical Teaching Fellow in Orthodontics, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00957489
- Sponsor's protocol ID
- DTT project
- Status last verified
- May 2023
- First submitted
- 11 Aug 2009
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion
- ClinicalTrials.gov ID
- NCT00957489
- Acronym / sponsor ID
- DTT project
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Orthodontic treatment of Class II division 1 malocclusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to increased harm and slow progress in the intervention group.
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 12 Aug 2009 (estimated)
- 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.
Twin-Block treatment and Dynamax treatment for Class II division 1 malocclusion do not have different effects with regards to treatment duration, the quality of dento-occlusal outcome, skeletal and soft tissue profile, patient discomfort and gingival health.
Detailed description
The Dynamax appliance is a relatively new appliance for the treatment of Class II malocclusion and was introduced in 2003. The appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. Furthermore, the Dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. There has been limited research into this appliance and only one trial has been carried out. In this study the effects of the Dynamax were compared with the Twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. For example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. This raises the question about the efficiency of the Dynamax appliance and whether or not they are effective in a 'real' world setting.
The aim of this study is to compare the effectiveness of the Dynamax appliance and the Twin-block appliance for the treatment of Class II Division 1 malocclusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional appliance-Dynamax | Experimental | Other: Dynamax appliance |
| Functional appliance- twin block | Other | Other: Twin-block applianceConventional treatment |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients with a Class II malocclusion as defined by British Standards Institute classification.
- Overjet greater than 6mm
- Aged 10-14 years
- Clinical examination indicates a functional appliance is not contraindicated
Key exclusion criteria (5 listed)
- Orthognathic treatment is required or there is a strong indication it will be required in the future
- Possession of a craniofacial anomaly
- Previous orthodontic treatment and/or premolar extraction
- Hypodontia of more than one teeth in any quadrant excluding third molars
- Inadequate oral hygiene
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 |
|---|---|---|
| Dynamax appliance | Other | Functional appliance-Dynamax |
| Twin-block appliance | Other | Functional appliance- twin block |
Primary outcome
Duration of treatment with functional appliance
Time frame: 9 months
Overjet measurement
Time frame: 9 months
1 secondary outcome
Harms Breakages Number of treatment visits Total treatment time Quality of occlusal result (PAR Index) Restricted cephalometric (radiograph) analysis Patient perception questionnaire at six months into treatment
Time frame: 9 months
Results and safety
The study was stopped early (reason given: Study stopped due to increased harm and slow progress in the intervention group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
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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
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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.
Kevin O'Brien, BDS, MSc, FDSRCS, DORth, PhD principal investigator
Prof of Orthodontics/ Associate Dean Teaching and Learning, University of Manchester
Jonathan Sandler, BDS, MSc, FDSRCS, MOrth RCS principal investigator
Consultant Orthodontist, Chesterfield NHS Trust
Alison Murray, BDS, MSc, FDSRCS, MORth RCS principal investigator
Consultant Orthodontist, Derby NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamax appliance and Twin-block appliance in people with Class II Division 1 Malocclusion, run by University of Manchester at 2 sites in United Kingdom.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
The study was stopped early (reason given: Study stopped due to increased harm and slow progress in the intervention group.). 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?
Duration of treatment with functional appliance (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.