A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

NCT ID: NCT02866929

Last Updated: 2018-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

Class I Malocclusion; Other Periodontal Diseases; Thin Gingival Biotype

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional orthodontic treatment

Patients that will receive conventional orthodontics

Group Type: ACTIVE_COMPARATOR

Orthodontics

Intervention Type: DEVICE

Self-ligation brackets in upper and lower teeth

Orthodontics with decortication

Patients that will receive orthodontic treatment with selective alveolar decortication

Group Type: EXPERIMENTAL

Decortication

Intervention Type: PROCEDURE

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.

Orthodontics

Intervention Type: DEVICE

Self-ligation brackets in upper and lower teeth

Orthodontics decortication and Mucograft

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

Group Type: EXPERIMENTAL

Decortication

Intervention Type: PROCEDURE

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.

Orthodontics

Intervention Type: DEVICE

Self-ligation brackets in upper and lower teeth

Mucograft

Intervention Type: DRUG

Porcine naturally cross-linked collagen matrix

Orthodontics and Mucograft®

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

Group Type: EXPERIMENTAL

Orthodontics

Intervention Type: DEVICE

Self-ligation brackets in upper and lower teeth

Mucograft

Intervention Type: DRUG

Porcine naturally cross-linked collagen matrix

Interventions

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.

Intervention Type: PROCEDURE

Orthodontics

Self-ligation brackets in upper and lower teeth

Intervention Type: DEVICE

Mucograft

Porcine naturally cross-linked collagen matrix

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: collaborator

Universidad del Valle, Colombia

OTHER

Sponsor Role: collaborator

CES University

OTHER

Sponsor Role: lead

Responsible Party

Maria Antonia Alvarez

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ODCES001

Identifier Type: -

Identifier Source: org_study_id