Clinical trial NCT02866929: A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics
Official title: Molecular Evaluation of Inflammatory and Bone Remodeling Markers in Gingival Crevicular Fluid After Selective Alveolar Decortication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Class I Malocclusion
Other Periodontal Diseases
Thin Gingival Biotype
Keywords: orthodontics
periodontics
piezosurgery
accelerated orthodontics
Surgically Accelerated Orthodontic Treatment
Lead sponsor: CES University
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Universidad del Valle, Colombia
First posted: 2016-08-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models.
timeFrame: 2 years
Secondary outcomes:
measure: Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement.
timeFrame: 4 weeks
measure: Determining the safety and efficacy of the Mucograft by comparing periodontal stability at baseline and post-treatment, taking clinical periodontal measures.
timeFrame: 2 years
measure: Measuring tooth movement rate based on changes of tooth alignment using superimposition of digital impressions of the mandibular anterior region of interest.
timeFrame: 2 years
Other outcomes:
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