Malocclusion, Angle Class IINCT03450551
Comparison of Efficacy of Three Orthodontic Appliances
A study testing Twin Block, Herbst, Frog distalising appliance in people with Malocclusion, Angle Class II, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
To investigate each treatment modality in its "optimal" environment to avoid operator experience bias. Therefore we propose to operate out of three "specialist centres" with specific units providing one modality alone Which of the three orthodontic appliances does achieve best clinical progress, produce least… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Angle Class II
- What is being tested?
- Twin Block, Herbst, Frog distalising appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to Aug 2019
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 10-16 years of age in the late mixed/permanent dentition with Class II malocclusions (Both Cl II div 1 and Cl II div 2)
- > 1/2 unit Class II molar relationship bilaterally (at least 3.5mm)
- Normal or deep overbite cases will be included
- Skeletal Class II relationship (ANB > 4°)
- Overjet ≥ 5 mm in Cl II/1 cases
- Non-extraction cases
Who cannot join
- Children in the early mixed dentition
- Class I and Class III malocclusions
- Malocclusions with less than 1/2 unit II molar relationship
- Reduced overbite / anterior openbite
- Medically compromised patients, syndromic patients or patients with severe facial asymmetry
- Special needs patients not able to comply with instructions / difficulty with compliance
- Hypodontia or extracted permanent tooth (except third molars)
- Poor oral hygiene with both Gingival bleeding Index and Plaque Index scoring no more than 1
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Clinical Efficacy of Three Class II Correctors in Orthodontics, Prospective Expertise Matched Controlled Trial
To investigate each treatment modality in its "optimal" environment to avoid operator experience bias. Therefore we propose to operate out of three "specialist centres" with specific units providing one modality alone Which of the three orthodontic appliances does achieve best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.
Read the detailed description
Patients and materials: The patient population will consist of patients age 10-16 that have, or are close to having, a full permanent dentition, and present to the clinic with Class II malocclusions with more than 1/2 unit II molar relationship. (Normal or deep overbite cases are also included). The treatments to be compared are the three (routinely-used) orthodontic appliances: Twin Block, Herbst and Frog.
Hypothesis: The principal (null) hypothesis is that there is no difference between the three appliances in terms of their effectiveness, efficiency and compliance.
Study design: The study is designed as a multicentre, Prospective Expertise Based Matched Controlled Longitudinal Trial and the assessments will be longitudinal in time.
All patients that consent/assent to be part of the study (and their parents) will receive an information leaflet about the study and will be asked to sign an assent form. Patients are free to discontinue treatment if they wish to do so. The normal length of orthodontic treatment is between 18 and 24 months. Assessments will be taken prior to treatment and throughout the treatment period, with regular progress reviews every 3 months, as per standard practice.
Outcomes: The principal outcome for efficiency is the time taken for completion of treatment. The principal outcomes for effectiveness are the clinical progress, discomfort (caused by the appliance to the patient) and compliance.
Clinical progress will be assessed by measuring tooth movement on each review appointment, using radiographic examination (DPT and lateral cephalograms). Each patient will record discomfort in a visual analogue scale (VAS or Likert scale)and compliance by writing the days the appliance was not in the mouth for any reason.
Covariates: Socio-economic variables: age, gender, etc.
- Conditions
- Malocclusion, Angle Class II
- Being tested
- Twin Block, Herbst, Frog distalising appliance
- 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.
Twin Block, Herbst, Frog distalising applianceDevice
To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.
| Study group | Role | What they receive |
|---|---|---|
| Twin Block | Experimental | 61 patients will receive the Twin Block appliance (one of the three appliances being studied) Receives: Device: Twin Block, Herbst, Frog distalising appliance |
| Herbst | Active comparator | 61 patients will receive the Herbst appliance (one of the three appliances being studied) Receives: Device: Twin Block, Herbst, Frog distalising appliance |
| Frog distalising appliance | Active comparator | 61 patients will receive the Frog distalising appliance (one of the three appliances being studied) Receives: Device: Twin Block, Herbst, Frog distalising appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who have experienced discomfort related to wearing the appliance
This is to check which appliance produces more discomfort compared to the other appliances using the Likert scale. Each question on the scale asks to rate the pain as either (no pain, slight pain, moderate pain, severe pain) or (strongly disagree, disagree, agree, strongly agree). Patients will choose a response which matches their experience.
Measured: 18-24 months
establishing which appliance has the fastest completion time
The three appliances will be compared in 'months' from the start of treatment till the completion of treatment to see which is the fastest to achieve the end result
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Apr 2018 (estimated)
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malocclusion, Angle Class IIStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 183 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dirk Bister, Consultant, Principal investigator, Guy's and St Thomas NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450551
- Sponsor's protocol ID
- 108653
- Status last verified
- Feb 2018
- First submitted
- 4 May 2017
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: No personal patient details will be shared. Only study data collected.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Efficacy of Three Class II Correctors in Orthodontics, Prospective Expertise Matched Controlled Trial
- ClinicalTrials.gov ID
- NCT03450551
- Acronym / sponsor ID
- 108653
- Conditions
- Malocclusion, Angle Class II
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 183 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 1 Mar 2018 (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.
To investigate each treatment modality in its "optimal" environment to avoid operator experience bias. Therefore we propose to operate out of three "specialist centres" with specific units providing one modality alone Which of the three orthodontic appliances does achieve best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.
Detailed description
Patients and materials: The patient population will consist of patients age 10-16 that have, or are close to having, a full permanent dentition, and present to the clinic with Class II malocclusions with more than 1/2 unit II molar relationship. (Normal or deep overbite cases are also included). The treatments to be compared are the three (routinely-used) orthodontic appliances: Twin Block, Herbst and Frog.
Hypothesis: The principal (null) hypothesis is that there is no difference between the three appliances in terms of their effectiveness, efficiency and compliance.
Study design: The study is designed as a multicentre, Prospective Expertise Based Matched Controlled Longitudinal Trial and the assessments will be longitudinal in time.
All patients that consent/assent to be part of the study (and their parents) will receive an information leaflet about the study and will be asked to sign an assent form. Patients are free to discontinue treatment if they wish to do so. The normal length of orthodontic treatment is between 18 and 24 months. Assessments will be taken prior to treatment and throughout the treatment period, with regular progress reviews every 3 months, as per standard practice.
Outcomes: The principal outcome for efficiency is the time taken for completion of treatment. The principal outcomes for effectiveness are the clinical progress, discomfort (caused by the appliance to the patient) and compliance.
Clinical progress will be assessed by measuring tooth movement on each review appointment, using radiographic examination (DPT and lateral cephalograms). Each patient will record discomfort in a visual analogue scale (VAS or Likert scale)and compliance by writing the days the appliance was not in the mouth for any reason.
Covariates: Socio-economic variables: age, gender, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Twin Block | Experimental | Device: Twin Block, Herbst, Frog distalising appliance61 patients will receive the Twin Block appliance (one of the three appliances being studied) |
| Herbst | Active comparator | Device: Twin Block, Herbst, Frog distalising appliance61 patients will receive the Herbst appliance (one of the three appliances being studied) |
| Frog distalising appliance | Active comparator | Device: Twin Block, Herbst, Frog distalising appliance61 patients will receive the Frog distalising appliance (one of the three appliances being studied) |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Patients aged 10-16 years of age in the late mixed/permanent dentition with Class II malocclusions (Both Cl II div 1 and Cl II div 2)
- > 1/2 unit Class II molar relationship bilaterally (at least 3.5mm)
- Normal or deep overbite cases will be included
- Skeletal Class II relationship (ANB > 4°)
- Overjet ≥ 5 mm in Cl II/1 cases
Key exclusion criteria (8 listed)
- Children in the early mixed dentition
- Class I and Class III malocclusions
- Malocclusions with less than 1/2 unit II molar relationship
- Reduced overbite / anterior openbite
- Medically compromised patients, syndromic patients or patients with severe facial asymmetry
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 |
|---|---|---|
| Twin Block, Herbst, Frog distalising applianceTo study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance. | Device | Frog distalising appliance, Herbst, Twin Block |
Primary outcome
Number of participants who have experienced discomfort related to wearing the appliance
Time frame: 18-24 months
This is to check which appliance produces more discomfort compared to the other appliances using the Likert scale. Each question on the scale asks to rate the pain as either (no pain, slight pain, moderate pain, severe pain) or (strongly disagree, disagree, agree, strongly agree). Patients will choose a response which matches their experience.
establishing which appliance has the fastest completion time
Time frame: 18-24 months
The three appliances will be compared in 'months' from the start of treatment till the completion of treatment to see which is the fastest to achieve the end result
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: Yes. No personal patient details will be shared. Only study data collected.
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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.
Dirk Bister, Consultant principal investigator
Guy's and St Thomas NHS Trust
Questions about this trial
What is this clinical trial studying?
A study testing Twin Block, Herbst, Frog distalising appliance in people with Malocclusion, Angle Class II, run by Guy's and St Thomas' NHS Foundation Trust.
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 6 inclusion and 8 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Inas Nasr, Consultant (+447719595027, inasnasr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have experienced discomfort related to wearing the appliance (time frame: 18-24 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 1 Mar 2018.