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CLASS II DIVISION 1 MALOCCLUSIONNCT07292636

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

A study testing CTB and CMA in people with CLASS II DIVISION 1 MALOCCLUSION and Class II Malocclusion, run by Aslam Alkadhimi at 1 site in Ireland.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The investigators of this clinical trial aim to: Compare the effectiveness and efficiency of Clark's Twin Block Appliance (CTB) vs Carriere Motion Appliance (CMA) in correcting Class II malocclusion when used in post-pubertal older adolescents, in terms of skeletal and dental change. Read more about this study

Who is it for?
Ages 14 years and older
What is being tested?
CTB and CMA
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteIreland
Study dates
Mar 2026to Sep 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • males and females aged 14 ½ -16 years from the HSE waiting list,
  • Cervical Vertebral Maturation (CVM) stage ≥5,
  • a mild-moderate skeletal II pattern,
  • normodivergent with average maxillomandibular planes angle (MMPA: 27±4 degrees),
  • Class II division 1 incisor relationship,
  • Class II molar relationship of ≥1/2 unit bilaterally,
Show all 9Show fewer
  • overjet of ≥7 mm,
  • ≤5mm of dental crowding in both arches and
  • fluent English speaker.

Who cannot join

  • high MMPA,
  • low MMPA,
  • have/had cleft lip or palate or craniofacial syndrome,
  • hypodontia,
  • gross mandibular asymmetry,
  • a medically diagnosed growth excess or deficiency,
  • not dentally fit or
  • had previously received orthodontic treatment.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Prof Padhraig Fleming contact

0035316127252

padhraig.fleming@dental.tcd.ie

Ireland1 site
  • Ashtown Gate HSE Orthodontic Unit

    Dublin, Dublin, D 15

    Aslam Alkadhimi, 00353863881553, aslam.alkadhimi@hse.ie

Other trials in Ireland

About this study

Official title: 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: A Randomised Controlled Trial

The investigators of this clinical trial aim to:

  • Compare the effectiveness and efficiency of Clark's Twin Block Appliance (CTB) vs Carriere Motion Appliance (CMA) in correcting Class II malocclusion when used in post-pubertal older adolescents, in terms of skeletal and dental change.
  • Evaluate potential negative oral health-related quality of life (OHRQoL) impacts during the active treatment phase with either CTB or CMA in post-pubertal adolescents.
  • Investigate the impact of Class II malocclusion on oral health-related quality of life (OHRQoL) in post-pubertal adolescents.
Read more

Class II division 1 malocclusion is a dental condition where the upper teeth protrude significantly over the lower teeth. It is a common type of malocclusion observed in orthodontic practice, accounting for approximately 20-25% globally. Correcting Class II malocclusion in growing patients using functional appliances and Class II correctors is relatively predictable.

In Ireland and the United Kingdom, the Clark's Twin Block (CTB) is the most commonly used functional appliance. The CTB consists of two components: one for the upper teeth and one for the lower teeth. These components are engineered to position the lower jaw forward, thereby promoting the desired dentoskeletal changes (moving the upper teeth back and lower forward). Another device used for Class II correction is the Carriere Motion Appliance (CMA). The CMA is gaining popularity as a treatment option for Class II malocclusion, inducing dental changes similar to those achieved with a CTB. However, uncertainty persists regarding the effectiveness of these appliances in older adolescents in the post-pubertal growth phase (aged approximately 14.5 years or above).

Additionally, although both CTB and CMA are effective in growing patients in correcting dental and skeletal discrepancies, they may influence daily activities, comfort, and psychological aspects, which often results in poor compliance. Poor adherence to orthodontic treatment, whether with fixed or removable appliances, can lead to higher rates of treatment failure.

Read the detailed description

Introduction:

Multiple treatment approaches are available to address the Class II byccal segment relationship characteristic of this type of malocclusion. However, the treatment approach depends on various factors, with chronological and skeletal age being pivotal. Typically, patients present with an underlying Class II skeletal pattern characterised by mandibular retrusion.

In growing patients, treatment often involves growth-dependent strategies, such as functional appliances or other Class II correctors. While these approaches primarily produce dentoalveolar effects, with less than one-third of the correction achieved by functional appliances attributable to skeletal changes, understanding the distinction between skeletal and dentoalveolar impacts is crucial. This differentiation informs treatment choice by highlighting the varying degrees to which these methods can achieve skeletal versus dental corrections, essential for tailoring patient-specific plans.

A continuing discussion exists regarding the ability of functional appliances, whether removable or fixed, to provide effective short- and long-term stimulation of mandibular growth. While this discussion endures, it is widely recognised that the majority of correction achieved with these appliances tends to be dentoalveolar rather than skeletal in nature, with only a modest proportion attributable to true mandibular advancement. Furthermore, these dentoalveolar effects are not exclusive to functional appliances, as similar outcomes have been documented with alternative Class II correctors such as the Carriere Motion Appliance, as detailed in subsequent studies.

Some researchers propose that functional appliances yield favourable outcomes by promoting mandibular growth, either through increased mandibular length or condylar growth. Conversely, other studies contend that the extent of these skeletal effects is limited. Consequently, substantial evidence indicates that dentoalveolar changes resulting from functional appliance treatment exceed the skeletal changes.

Correcting Class II malocclusion in growing patients using functional appliances and Class II correctors is relatively predictable. However, uncertainty persists regarding the effectiveness of these appliances in older adolescents in the post-pubertal growth phase (aged approximately 14.5 years or above). Limited evidence from two retrospective studies suggests that CTB and fixed functional appliances remain effective in patients with mean ages of 13.73 ± 1.51 years and 13.76 ± 1.44 years, respectively. Furthermore, a recent randomised controlled trial (RCT) demonstrated that CTB yielded comparable effects in patients aged 11 years 8 months to 12 years 8 months, relative to those who initiated treatment 18 months later. However, the interval of active treatment between the immediate treatment group and the later treatment group may not have been sufficient to reveal significant differences in treatment outcomes. The delay for the late-treatment group was constrained by the current waiting list durations in this study.

There is a notable lack of literature regarding the effectiveness of functional appliances and other Class II correctors in post-pubertal patients.

Oral Health Related Quality of Life associated with Class II and its treatment Although both CTB and CMA are effective in growing patients in correcting dental and skeletal discrepancies, they may influence daily activities, comfort, and psychological aspects, which often results in poor compliance. Poor adherence to orthodontic treatment, whether with fixed or removable appliances, can lead to higher rates of treatment failure. To address these compliance challenges, our study will use wear-time sensors in the CTBs to objectively monitor appliance adherence.

Several generic measures are used to assess oral health-related quality of life (OHRQoL) across various dental conditions. One such measure is the Child Oral Health Impact Profile (COHIP), which is also available in a short form (COHIP-19). This questionnaire is a reliable and valid tool for assessing OHRQoL in patients aged 7 to 18 years.

However, generic measures may not fully capture condition-specific impacts. To address this limitation, condition-specific OHRQoL measures have been developed. The Malocclusion Impact Questionnaire (MIQ), initially developed and tested in the UK, provides a targeted assessment of the effects of malocclusion on young patients. The Orthodontic Treatment Impact Questionnaire (OTIQ) evaluates the daily impact of orthodontic appliances on adolescents and demonstrates strong construct validity, reliability, and internal consistency.

Statement of the problem:

The effectiveness of functional appliances and Class II correctors in treating Class II malocclusion is well known. However, treating older adolescents in the post-pubertal skeletal growth phase presents certain challenges that we aim to address:

  • To evaluate the effectiveness and efficiency of CTB and CMA in older adolescents who have completed their skeletal growth spurt.
  • To assess the impact of CTB and CMA on OHRQoL, thereby informing treatment planning decisions and appliance wear protocols to improve treatment adherence.
  • Additionally, understanding the impact of Class II malocclusion on OHRQoL may assist orthodontists in preparing patients for treatment and involving them in the decision-making process.

Importance of this research:

  • The findings will provide insight into whether treatment initiated at an older age remains effective and into which of the two established treatment modalities is more effective and efficient.
  • Additionally, this research will elucidate both the potential benefits on oral health-related quality of life and the challenges and adjustments young patients encounter during treatment. Such knowledge may be invaluable for orthodontists in preparing patients for treatment, refining appliance design, and improving patient comfort and adherence.
  • Ultimately, these insights will inform patient selection and consent processes for older adolescent patients with Class II malocclusions.

Objectives:

The objectives of this clinical trial are to:

  • Compare the amount of dental and skeletal changes and time taken to achieve those changes between post-pubertal patients wearing CTB and CMA.
  • Assess the challenges and adjustments older adolescents face during CTB and CMA therapy through the completion of Orthodontic Treatment Impact Questionnaire (OTIQ).
  • Evaluate the OHRQoL associated with Class II malocclusion in older adolescents through the completion of the Malocclusion Impact Questionnaire (MIQ) and the Child Oral Health Impact Profile (COHIP-19) questionnaire.

Hypotheses:

  • Correction of Class II malocclusion with either CTB or CMA in post-pubertal older adolescents is effective, and both appliances are equally effective and efficient.
  • Class II correction with CTB and CMA has a beneficial effect on OHRQoL in older adolescents.
  • Class II malocclusion affects the OHRQoL of older adolescents negatively.
Being tested
CTB, CMA
Keywords
Class II Malocclusion, Overjet, Class II Molar Relationship, Class II Canine Relationship, Functional Appliance, Class II Corrector, Growth Modification, Oral Health Related Quality of Life, Twin Block, Carriere Motion Appliance, RCT
Medical subject headings
Malocclusion, Angle Class II, Overbite

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTBDevice

    The appliance will be used with the bite registration taken in maximum protrusion incorporating the following features: (1) Adam's clasps on all first premolars and first permanent molars, (2) three ball-ended clasps on the mandibular incisors, (3) midline expansion screw in the maxillary component, (4) blocks intersecting at 70 degrees, with a height of 5-6 mm in the premolar region. Patients will be instructed to wear the appliance full-time, except for eating, and during contact or water sports. Objective wear time in minutes will be recorded by a Theramon® microsensor (Handelsagentur Gschladt, Hargelsberg, Austria, or Forestadent, Pforzheim, Germany) placed in the maxillary component.

  • CMADevice

    The appliance consists of rigid stainless-steel or acrylic bars bonded to the maxillary canines and first molars bilaterally. Elastics will be worn in a Class II pattern, from hooks on the maxillary canine to attachments on the mandibular first molar (bonded molar tubes). Anchorage in the mandibular dentition will be provided by an Essix-type retainer. Patients will be instructed to wear elastics full time except for eating and cleaning the teeth. The elastics protocol for the CMA appliance will be: Force 1 elastics (Henry Schein Orthodontics) that generate about 375 g of force that will be used during the first 6 weeks, changed to Force 2 elastics that generate about 540 g of force thereafter.

Study groups in NCT07292636
Study groupRoleWhat they receive
CTB groupActive comparatorParticipants assigned to this group will receive CTB.
Receives: Device: CTB
CMA groupExperimentalParticipants assigned to this group will receive CMA.
Receives: Device: CMA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in molar and canine relationship at T3 (effectiveness)

    The primary outcome measure (change in molar and canine relationship) will be calculated at T3. This will be calculated by measuring the difference from T0 to T3 in the horizontal plane (in mm);

    • from the cusp tip of maxillary canine relative to the distal contact point of the opposing mandibular canine (change in canine relationship) and
    • from the mesiobuccal cusp of maxillary first molar relative to the buccal groove of mandibular first molar (change in molar relationship).

    All the measurements will be performed on dental study casts (taken at T0 and T3) articulated in maximum intercuspation position (MIP) using a vernier calliper. Measurements from right and left sides will be taken. Change in the canine and molar relationship will be calculated as the difference from T0 to T3.

    Measured: T3: 9 months

Secondary outcomes (5)
  1. Change in molar and canine relationship at T2 (efficiency)

    The secondary outcome measure (change in molar and canine relationship) will be calculated at T2. This will be calculated by measuring the difference from T0 to T2 in the horizontal plane (in mm);

    • from the cusp tip of maxillary canine relative to the distal contact point of the opposing mandibular canine (change in canine relationship) and
    • from the mesiobuccal cusp of maxillary first molar relative to the buccal groove of mandibular first molar (change in molar relationship).

    All the measurements will be performed on intra-orally (taken at T0 and T2) using a vernier calliper. Measurements from right and left sides will be taken.

    Measured: T2: 18 weeks

  2. Dentoskeletal cephalometric changes at T3

    Cephalometric dentoskeletal measurements (sagittal maxillary skeletal, sagittal mandibular skeletal, angular maxillomandibular, vertical skeletal and dentoalveolar). Each T0 and T3 lateral cephalogram will be obtained from the same machine and will be analysed by orienting it so that the Frankfurt plane is parallel to the floor, with the same magnification factor.

    Measured: T3: 9 months

  3. Impact of treatment on daily life based on the Orthodontic Treatment Impact Questionnaire (OTIQ) scores at T1 and T3

    Evaluate potential negative oral health-related quality of life impacts during the active treatment phase with either CTB or CMA in post-pubertal adolescents. The Orthodontic Treatment Impact Questionnaire (OTIQ) is used to assess the day-to-day impact of any orthodontic appliance on adolescents, possessing good construct validity, reliability, and internal consistency.

    The OTIC score ranges from 0 to 44. Higher scores on the OTIQ indicate lower OHRQoL.

    Measured: T1: 2 weeks; T3: 9 months

  4. Impact of Class II correction on oral health-related quality of life (OHRQoL) based on the Malocclusion Impact Questionnaire (MIQ) scores at T0 and T4

    The impact of Class II malocclusion on oral health-related quality of life (OHRQoL) in post-pubertal adolescents, will be investigated. The Malocclusion Impact Questionnaire (MIQ) will be used to assess this outcome.

    MIQ score ranges from 0 to 34. Higher MIQ scores indicate greater negative impact of malocclusion on OHRQoL.

    Measured: T0: Baseline; T4: 42 weeks

  5. Impact of Class II correction on oral health-related quality of life (OHRQoL) based on the Child Oral Health Impact Profile (COHIP-19) scores at T0 and T4

    The impact of Class II malocclusion on oral health-related quality of life (OHRQoL) in post-pubertal adolescents, will be investigated. The Child Oral Health Impact Profile (COHIP), available as a short form (COHIP-19) will be used to assess this outcome.

    COHIP-19 score ranges from 0 to 76. Higher COHIP-19 score indicate greater OHRQoL.

    Measured: T0: Baseline; T4: 42 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study startMar 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2029 (estimated)

Resources

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
Model description
Trial design: Two-arm, parallel group. Conceptual framework: Superiority trial. Allocation ration: A 1:1 allocation ratio.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07292636
Sponsor's protocol ID
250901
Status last verified
Dec 2025
First submitted
3 Dec 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is a plan to make IPD and related data dictionaries available after trial completion.

Questions about this trial

What is this clinical trial studying?

A study testing CTB and CMA in people with CLASS II DIVISION 1 MALOCCLUSION and Class II Malocclusion, run by Aslam Alkadhimi at 1 site in Ireland.

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 9 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: opening soon, as of the sponsor's last update on 18 Dec 2025. 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 Ireland. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Prof Padhraig Fleming (0035316127252, padhraig.fleming@dental.tcd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in molar and canine relationship at T3 (effectiveness) (time frame: T3: 9 months). 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 18 Dec 2025.

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