A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

Study Overview
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Brief Summary
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Numerous treatment protocols geared towards accelerating orthodontic treatment have emerged in the past few years as an appealing alternative for patients and practitioners. In the context of a thin biotype, these approaches pose a burden that could precipitate periodontal detrimental changes. Therefore, case selection and the implementation of periodontal biotype enhancing strategies become a relevant consideration to ensure long-term successful treatment outcomes. This study focuses on the biological and clinical value of the use of a porcine naturally cross-linked collagen matrix known as Mucograft®. Within the scope of Surgically Accelerated Orthodontic Treatment (SAOT) the structural and material features of Mucograft® provide: 1) A protective effect to the thin biotype upon rapid orthodontic protusive/proinclination movements and 2) Mucograft® enhances the therapeutic window effect that supports an increase on tooth movement rate. The designs of this randomized controlled clinical trial includes a cohort of 40 subjects distributed on the following groups I) Ortho tx, II) Ortho tx + Decortication, III) Ortho tx + Decortication + Mucograft®, and IV) Ortho tx + Mucograft®. Comparing clinical, tomographic and digital impression derived measurements will capture the clinical phenotype; while the biologic phenotype will be derived from evaluating crevicular fluid levels of tooth movement mediators such as Interleukin 1-β and Interleukin-1RA. The significance and innovative value of this proposal stems from the use of Mucograft® as an ideal collagen-based biotype enhancer when performed along with the corticotomy. This approach could prove to be effective to further increase the therapeutic window that allows accelerating orthodontic treatment and, at the same time, could decrease the recession risk in movements of proclination of antero-inferior incisors. Besides, the use of a collagen scaffold alone could potentially trigger a comparable orthodontic acceleratory outcome that could be evaluated as an alternative to decortication.

Official Title
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Molecular Evaluation of Inflammatory and Bone Remodeling Markers in Gingival Crevicular Fluid After Selective Alveolar Decortication

Conditions
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Class I Malocclusion, Other Periodontal Diseases, Thin Gingival Biotype

Intervention / Treatment
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* Procedure: Decortication
* Device: Orthodontics
* Drug: Mucograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Angle's class I malocclusion Little's grade II or III dental crowding Periodontally stable patients Patients with no more than 2 mm of keratinized gingiva in at least two sites of the antero-inferior region Exclusion Criteria: Patient with presence of marginal tissue recessions on inferior incisors Patients with a metabolic or neoplastic alteration History of orthopedic surgery in the last 6 months History of fractures in the last 6 months History of bisphosphonates use Patient with systemic compromise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional orthodontic treatment<br>Patients that will receive conventional orthodontics | Device: Orthodontics<br>* Self-ligation brackets in upper and lower teeth<br>|
| Experimental: Orthodontics with decortication<br>Patients that will receive orthodontic treatment with selective alveolar decortication | Procedure: Decortication<br>* Under local anesthesia, vertical and inter-radicular gingival incisions will be performed on the vestibular of the maxillary and mandibular arch, starting 2-3 mm below the interdental papilla and with sufficient depth to the periosteum to allow the scalpel to reach the alveolar bone. These incisions will be kept as small as possible; then, through them, using a piezoelectric scalpel (piezotome), several bone cuts will be performed. These cuts will have sufficient depth for drilling the cortical alveoli.<br>Device: Orthodontics<br>* Self-ligation brackets in upper and lower teeth<br>|
| Experimental: Orthodontics decortication and Mucograft<br>Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment | Procedure: Decortication<br>* Under local anesthesia, vertical and inter-radicular gingival incisions will be performed on the vestibular of the maxillary and mandibular arch, starting 2-3 mm below the interdental papilla and with sufficient depth to the periosteum to allow the scalpel to reach the alveolar bone. These incisions will be kept as small as possible; then, through them, using a piezoelectric scalpel (piezotome), several bone cuts will be performed. These cuts will have sufficient depth for drilling the cortical alveoli.<br>Device: Orthodontics<br>* Self-ligation brackets in upper and lower teeth<br>Drug: Mucograft<br>* Porcine naturally cross-linked collagen matrix<br>|
| Experimental: Orthodontics and Mucograft®<br>Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment | Device: Orthodontics<br>* Self-ligation brackets in upper and lower teeth<br>Drug: Mucograft<br>* Porcine naturally cross-linked collagen matrix<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement. |  | 4 weeks | 
| Determining the safety and efficacy of the Mucograft by comparing periodontal stability at baseline and post-treatment, taking clinical periodontal measures. |  | 2 years | 
| Measuring tooth movement rate based on changes of tooth alignment using superimposition of digital impressions of the mandibular anterior region of interest. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthodontics, periodontics, piezosurgery, accelerated orthodontics, Surgically Accelerated Orthodontic Treatment