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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

ConditionsCLASS II DIVISION 1 MALOCCLUSIONClass II MalocclusionGrowthOverjetClass II Buccal Segment RelationshipClass II Growth ModificationDistalizationOral Health-Related Quality of Life
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorAslam Alkadhimi

About this 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.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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),

Disqualifiers

high MMPA,

low MMPA,

have/had cleft lip or palate or craniofacial syndrome,

hypodontia,

Trial design

Design model

Parallel

Treatments tested in this trial

  • CTB

    Device

    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.

  • CMA

    Device

    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.

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: CTB groupActive comparator 1 intervention
Group B: CMA groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
T3: 9 months

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
T0: Baseline; T4: 42 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aslam Alkadhimi

Lead sponsor

University of Dublin, Trinity College

Sponsor institution

Health Service Executive, Ireland

Collaborator

University of Dublin, Trinity College

Collaborator

Dublin Dental University Hospital

Collaborator

Source ClinicalTrials.gov

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