A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

CES University

Status and phase: Unknown; Phase 4

Conditions: Class I Malocclusion; Thin Gingival Biotype; Other Periodontal Diseases

Treatments: Drug: Mucograft; Procedure: Decortication; Device: Orthodontics

Study type: Interventional

Funder types: Other

Identifiers

NCT02866929

ODCES001

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

Conventional orthodontic treatment

Active Comparator group

Description:

Patients that will receive conventional orthodontics

Treatment:

Device: Orthodontics

Orthodontics with decortication

Experimental group

Description:

Patients that will receive orthodontic treatment with selective alveolar decortication

Treatment:

Device: Orthodontics

Procedure: Decortication

Orthodontics decortication and Mucograft

Experimental group

Description:

Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment

Treatment:

Device: Orthodontics

Drug: Mucograft

Procedure: Decortication

Orthodontics and Mucograft®

Experimental group

Description:

Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment

Treatment:

Device: Orthodontics

Drug: Mucograft