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NCT07404696
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.
NCT05227859
Sixty patients requiring extraction-based treatment of the maxillary first premolars, followed by retraction of the maxillary canines, will be randomly assigned to three groups: piezocision, low-level laser therapy, and control. In each group, canine retraction will be initiated after completion of the leveling and alignment phase, using closed nickel-titanium coil springs that apply 150 g of force per side. For anchorage, a soldered transpalatal arch will be used. Pre- and post-distalization dental casts will be assessed to evaluate the rate of canine retraction, canine rotation, and anchorage loss over the follow-up period until a Class I canine relationship is achieved. Periodontal health will be assessed before and after canine retraction by evaluating the following parameters: plaque index, gingival index, bleeding index, and probing depth.
NCT07292636
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.
NCT07270653
Assesment of TMJ changes after treatment of skeletal classII growing patients by Twinblock vs Mono block applinces
NCT07243509
Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched. This study aims to compare two groups of patients with mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°), a normal to slightly increased vertical growth pattern (Björk's sum \> 390° and \< 406°), and an overjet of 5-10 mm. Experimental group: the patients in this group will be treated in the canine retraction phase with a sliding on a round-section archwire of 0.020 inch Control group: the patients in this group. Maxillary canine distalization was carried out using sliding mechanics on a 0.019 × 0.025-inch stainless steel archwire.
NCT04508322
Class II malocclusion with excessive overjet is one of the most common malocclusions among children and adolescents. The overall goal of the project is to analyze orthodontic treatment of Class II malocclusion with excessive overjet when the treatment is started in different ages and treated with removable and/or fixed appliance. Treatment initiated before the age of eleven is performed with a removable functional appliance, Headgear Activator (HGA). Treatment starting in early adolescence is performed with fixed orthodontic appliance (FA). The hypotheses are: * Treatment with HGA at the age of nine or eleven is effective. No spontaneous correction of the malocclusion is expected in the untreated control group. * Patient experience, treatment effect and cost-effectiveness are equivalent whether the treatment with HGA is initiated at the age of nine or eleven. * Treatment results, patient experience and treatment- and cost-effectiveness are equivalent whether treatment is initiated early with HGA or initiated in early adolescence with FA. * The treatment of Class II malocclusion with excessive overjet renders long-term treatment stability and patient satisfaction.
NCT06726694
the primary aim for this clinical trial was to assess the amount of molar distalization The subjects with the following inclusion criteria: 1. Early permanent dention. 2. Class II division 1 or class II division 2 dental occlusion. 3. Good oral hygiene. 4. No previous orthodontic treatment. 5. No history of serious medical problems such as diabetes or autoimmune disease, allergies or bone disease. 6. Good periodontal support of the upper molar.
NCT06403033
Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.
NCT06232928
This clinical trial aimed to compare the effect of immediate light short Class II elastics versus conventional Class II elastics on the skeletal, dental and soft tissues in patients with Class II malocclusion. Participants with class II malocclusion divided into 2 groups; early group wore immediate light short Class II elastics and conventional group wore conventional Class II elastics on rigid stainless steel arch wires.
NCT05652244
Thirty-eight patients requiring extraction of maxillary first premolars will participate in the study. They will be divided randomly into two groups: an en-masse retraction group and a two-step group. In each group, anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, Mini-implants will be used as an anchor unit in the en-masse retraction group, and TPA in the two-step's retraction group. The levels of pain, discomfort, and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale.
NCT05335824
60 patients needed therapeutic extraction of the maxillary first premolars with subsequent retraction of the maxillary canines were divided to randomly three groups: (1) PRP group: Received PRP injections, (2) I-PRF group: Received I-PRF injections, (3) Control group: conventional treatment with no injections. TPAs were used as an anchor unit. Coil springs were used to distalize the upper canines on 0.019 x 0.025-inch stainless archwires. Alginate impressions and dental casts of the maxillary arch were done at five-time points over a 4-month follow-up period. The amount of canine movement, canine rotation, and anchorage loss were measured on three-dimensional digital models superimposed on the rugae area.
NCT05166928
This clinical study will be directed to compare the effect of presence or absence of third molar on distalization of the upper posterior segment by using carriere motion appliance
NCT04847492
This study aims to assess the dental changes, periodontal health and the pulp vitality in mini-screw supported en-masse retraction associated with traditional or flapless corticotomy techniques. 40 adult patients exhibiting class II division 1 malocclusion requiring upper first premolar extractions followed by en-masse retraction will participate in the study. They will be randomly and equally distributed into two groups: traditional corticotomy (20 patients) versus flapless corticotomy (20 patients). The corticotomy procedure will be performed pre-retraction. The dental changes will be assessed using dental casts. The impressions will be taken after finishing the leveling and alignment phase and before starting the en-masse retraction (T0), 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), and 5 months (T5) following the onset of en-masse retraction. The final impression will be considered at the end of the en-masse retraction (when the canines reach Class Ι relationship).
NCT04743700
Acceleration of orthodontic tooth movement persuades tremendous rise in the interest of adolescents and aduts, as it not only shortens the treatment duration but also lessens the incidence of white spot lesions, root resorption, periodontal and other soft tissue problems. Minimal invasive techniques i.e.both piezocision and micro-osteoperforations had promising results in accelerating tooth movement. Therefore current study will provide evidence for better minimal invasive technique in terms of reducing treatment time and patient comfort.
NCT04028661
The study is to evaluate the effect of 3D printed modified Twin Block Appliance on skeletal Class II profile correction. The null hypothesis of this research is that use of 3D Printed Twin Block is not able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with untreated growing Class II control subjects.
NCT03296644
The main objective of this prospective, controlled clinical study is: 1. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device in patients with Class II divison1 malocclusion. 2. To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device with the control group. The null hypothesis for this study is that Forsus and PowerScope2 are equally effective in the treatment of ClassII div1 malocclusion.
NCT01853995
The aim of the current controlled trial was to assess the possible net skeletal and dental effects of FLMGM treatment in relation to growth with emphasis on the contribution of skeletal and dental changes to sagittal correction of Cl II/1 malocclusion. The null hypothesis stated that there were no significant differences in dentoskeletal changes between FLMGM treated group and control untreated group.