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

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.

Study Overview

• Status: Unknown
• Conditions: Thin Gingival Biotype; Class I Malocclusion; Other Periodontal Diseases
• Intervention / Treatment: Device: Orthodontics; Procedure: Decortication; Drug: Mucograft

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional orthodontic treatment; Patients that will receive conventional orthodontics	Device: Orthodontics; Self-ligation brackets in upper and lower teeth
Experimental: Orthodontics with decortication; Patients that will receive orthodontic treatment with selective alveolar decortication	Device: Orthodontics; Self-ligation brackets in upper and lower teeth; 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.
Experimental: Orthodontics decortication and Mucograft; Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment	Device: Orthodontics; Self-ligation brackets in upper and lower teeth; 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.; Drug: Mucograft; Porcine naturally cross-linked collagen matrix
Experimental: Orthodontics and Mucograft®; Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment	Device: Orthodontics; Self-ligation brackets in upper and lower teeth; Drug: Mucograft; Porcine naturally cross-linked collagen matrix

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: CES University
• Collaborators: University of Michigan; Universidad del Valle, Colombia

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: July 6, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: orthodontics; piezosurgery; periodontics; accelerated orthodontics; Surgically Accelerated Orthodontic Treatment
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Malocclusion; Periodontal Diseases; Malocclusion, Angle Class I
• Other Study ID Numbers: ODCES001