Class II Division 1 Malocclusion Clinical Trial
Official title:
A Three Dimensional Comparative Evaluation of Distal Movement of Entire Maxillary Dentition Using Infrazygomatic Crest Miniscrews and Zygomatic Miniplates: A Randomized Clinical Trial
Verified date | June 2020 |
Source | Postgraduate Institute of Dental Sciences Rohtak |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with infrazygomatic miniscrews in comparison with zygomatic miniplate anchorage.
Status | Active, not recruiting |
Enrollment | 42 |
Est. completion date | October 2021 |
Est. primary completion date | April 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Non growing patients - Bilateral Class II molar relationship, defined by at least end-to-end molar relationship. - No or minor crowding in the mandible. - Treatment completion without any permanent teeth extracted (excluding third molars). - Both 1st and 2nd maxillary molars present on the side with a Class II relationship. - Horizontal to average growth pattern. Exclusion Criteria: - Subjects with a history of fixed orthodontic treatment. - Crossbite - Vertical growth pattern - Any systemic disease affecting bone and general growth - Poor oral hygiene - Cleft patients - Patients who fail to follow up or undergo complete treatment |
Country | Name | City | State |
---|---|---|---|
India | Post Graduate Institute of Dental Sciences | Rohtak | Haryana |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Dental Sciences Rohtak |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | distal movement of maxillary molars and central incisors measured in mm at crown and root levels | . distal movement of maxillary molars and central incisors measured in mm at crown and root levels achieved with infrazygomatic crest miniscrew in comparison with zygomatic miniplates on Cone Beam Computed Tomography | 28 months | |
Primary | root resorption of maxillary teeth | root resorption of maxillary incisors, canines, premolars and molars evaluated on Cone Beam Computed Tomography before and after distalization with infrazygomatic crest miniscrew in comparison with zygomatic miniplates | 28 months | |
Primary | patient experiences and quality of life with zygomatic miniplates and infrazygomatic crest miniscrews | patient experiences and quality of life with zygomatic miniplates and infrazygomatic crest miniscrew assessed using questionnaires given to patients for evaluating patient attitude,pain perception and quality of life at different time intervals. | 34 months | |
Primary | soft tissue profile changes | soft tissue profile changes after distalization evaluated on lateral cephalogram and the raters- orthodontist, laypersons,patients,parents and general dentists will assess changes in facial appearance on a visual analog scale with profile photographs | 34 months | |
Primary | occlusal status comparison | occlusal status changes pre and post treatment will be assessed using PAR index(peer assessment rating between 2 groups) | 34 months | |
Secondary | mandibular plane angle | changes in mandibular plane angle after distalization with infrazygomatic crest miniscrew in comparison with zygomatic miniplates | 28 months | |
Secondary | movement of maxillary central incisors and molars in vertical plane | movement of maxillary central incisors and molars in vertical plane assessed by measuring the perpendicular distance between the incisal edge/ mesio-buccal cusp to the palatal plane on Cone Beam Computed Tomography after distalization with infrazygomatic crest miniscrew in comparison with zygomatic miniplates | 28 months | |
Secondary | transverse changes | intercanine and intermolar changes in transverse plane pre and post distalization will be measured on CBCT | 28 months | |
Secondary | airway changes | Changes in the upper-airway size will be measured by using lateral cephalometric radiographs taken before and after distalization | 28 months |
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