NCT02866929

A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: CES University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Class I Malocclusion
• Other Periodontal Diseases
• Thin Gingival Biotype

Interventions

Type	Name	Description
PROCEDURE	Decortication	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.
DEVICE	Orthodontics	Self-ligation brackets in upper and lower teeth
DRUG	Mucograft	Porcine naturally cross-linked collagen matrix

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2016-08-15
• Last updated: 2018-07-20