Clinical Research Directory

Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.

Background Approximately 15% of children have a Class II malocclusion, where the maxilla is positioned anterior to the mandible, and around 90% of these children also present with an increased overjet. Increased overjet is associated with a higher risk of dental trauma and psychosocial consequences such as bullying and reduced oral health-related quality of life (OHRQoL). Functional orthodontic appliances (e.g., headgear-activator and Twin-block) have long been used to reduce overjet through dentoalveolar effects and by influencing mandibular position and growth. More recently, digital solutions such as Invisalign's mandibular advancement appliance have been introduced, with potential advantages including improved wear time and simultaneous tooth alignment. However, there is currently limited evidence regarding treatment outcomes, patient experience, and cost-effectiveness of these newer appliances compared with established functional appliances. Aim The primary aim is to compare treatment outcomes, patient experience, and cost-effectiveness of interceptive orthodontic treatment using three different appliances. The overall aim is to determine whether interceptive treatment of Class II malocclusion with large overjet is effective, and if so, which interceptive modality should be preferred. Study design and setting A total of 144 patients aged 9-13 years with Class II malocclusion and large overjet will be randomized into four groups: * Headgear-activator * Twin-block * Aligner Mandibular advancement * Control Participants will be treated at four Orthodontic Specialist Clinics within the National Health Service in Region Halland and Västra Götaland, Sweden. Treatments will be provided by two experienced orthodontic specialists. Follow-up and data collection Clinical examinations will be performed at: * Baseline (T0) * 9 months into treatment (T1) * End of treatment (T2) Appliance checks will occur every 8 weeks. Digital scans of the occlusion will be collected at T0, T1, and T2. Lateral cephalometric radiographs will be taken at T0 and T2. Outcomes and planned analyses The trial will generate three studies with distinct outcomes: 1. Treatment outcomes Primary outcome: dental treatment effectiveness measured as overjet reduction. Secondary outcomes: other dental variables, skeletal outcomes, and extraoral outcomes. 2. Patient-reported outcomes All treated patients will complete two digital questionnaires: * Child Perception Questionnaire (CPQ): assesses the child's perception of their teeth before and after treatment. * Orthodontic Treatment Impact Questionnaire (OTIQ): assesses the child's experience of orthodontic treatment and the appliance. These outcomes will be used to evaluate changes in OHRQoL from pre- to post-treatment and to compare experiences across treatment modalities. 3. Cost-effectiveness analysis The economic evaluation will include direct, indirect, and societal costs. Treatment duration, number and length of appointments, and cancellations/no-shows will be recorded. * Direct costs: premises, staff salaries, materials, and laboratory costs. * Indirect costs: parental loss of income due to absence from work. * Societal costs: direct + indirect costs. Costs will be related to treatment outcomes to estimate cost-effectiveness across the treatment arms. Additional comparison: early vs late treatment Furthermore, after completing 18 months the control group, and half of the functional appliance patients will receive treatment with fixed appliances. This enables an additional comparison of early interceptive treatment versus later treatment using the same outcomes: treatment effectiveness, patient-reported outcomes, and cost-effectiveness.

Ready-made vs. Custom-made Carriere Motion Appliance

The aim of this study is to evaluate the effect of custom-made CMA vs. the ready-made CMA.

Dentoskeletal Effects of 3D-Printed Fixed Twin Block Versus MARA Appliances in Management of Skeletal Class II

Objective: to evaluate the dentoskeletal effects of CAD/CAM 3D-Printed fixed twin block versus MARA appliances in the management of skeletal class II due to Mandibular Deficiency in Preadolescence Class II malocclusion is considered one of the most commonly observed problems among orthodontic patients, representing around one-third of the patients seeking orthodontic treatment reflecting a significant economic impact. Various removable and fixed functional appliances are commonly used to stimulate mandibular growth. Fixed Twin-block appliance has advantages compared with removable Twin-block and Herbst appliances. The mandibular anterior repositioning appliance is referred to as M.A.R.A. appliance. Materials and method: The study design is a randomized controlled trial in which the control group and intervention groups will be assessed as parallel groups with a 1:1:1 allocation ratio. Sixty subjects will be enrolled in this research. They will be divided equally into three groups: untreated control, MARA group and Twin block group

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

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.

Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy

Patient with class ii division 1 malocclusion who have mild increased overjet will be treated in this study. The efficacy of clear aligners in the treatment of Class II division 1 Malocclusion Using Intermaxillary Elastics will be assessed. The skeletal, dental and soft tissues changes resulted by this intervention will be studied and compared with the results of Traditional treatment with fixed appliances. There are two group: 1. a group of patients in which participants will be undergo to the clear aligners with class ii elastics. 2. a group of patients in which participants will be undergo to the traditional fixed appliances with class ii elastics.

Comparison of Distalization of Maxillary First and Second Molars Between a Miniscrew Implant Supported Device and Clear Aligners.

The goal of this randomized clinical trial is to compare distalization of maxillary first and second molars achieved with a device supported with mini screw implants in the palate (Advanced Molar Distalization Appliance, AMDA®) with distalization of maxillary first and second molars achieved with clear aligners (Spark®) supported by Class II elastics. The main questions it aims to answer are: Is there any difference in achieving upper molar distalization with the Advanced Molar Distalization Appliance (AMDA®) supported by miniscrew implants and with clear aligners (Spark®) supported by Class II elastics at the end of active distalization phase? Is there any difference between the two groups in the anchorage loss at the end of total treatment? Additionally, the differences in the movements of premolars, canines and incisors will be analyzed in all three planes of space (sagittal, transverse, vertical), as well as the duration of treatment between the two groups and subgroup comparisons will be performed regarding age, gender, presence of maxillary third molars and severity of malocclusion. Participants will be randomly assigned to the AMDA® or Spark® group. Treatment will take place at the Department of Orthodontics and participants will have to visit the clinic every 4-6 weeks for regular check ups. Intraoral scans, photographs and x-rays (panoramic x-ray, cephalometric x-rays) will be taken before treatment, at the end of active distalization phase and at the end of treatment.

Maxillary Segmental Distalization Using Digitally Printed Appliances

Evaluation of Maxillary Segmental Distalization Using Infrazygomatic versus Palatal Digitally Printed Skeletal Anchored Appliances.

Evaluation of Maxillary Molar Distalization With Two Bone Supported Protocols Using Cone Beam Computed Tomography

The goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander in bilateral distalization of maxillary molars using CBCT in Egyptian people. The main question it aims to answer are: • If bone supported Fast Back and bone supported modified Leaf Spring Self-Activated Expander will be effective in bilateral distalization of maxillary molars The patients will be selected according to the following criteria: 1. Patient with full permanent dentition. 2. Good oral hygiene. 3. None of the patients had received any orthodontic treatment. 4. Class II molar relationship. 5. Minimal or no crowding in the mandibular arch. 6. Non-extraction treatment plan with molar distalization. 7. Low angle cases. 8. No medical problems or active periodontal disease. Researchers will compare between bone supported Fast Back appliance and bone supported modified Leaf Spring Self-Activated and see if they will be effective in maxillary molars distalization.

Invisalign® System with Mandibular Advancement

The goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the Invisalign® System with mandibular advancement featuring occlusal blocks