A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

Thin Gingival Biotype Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02866929
• Other study ID #: ODCES001
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 2016
• Est. completion date: September 2018

Study information

• Verified date: July 2018
• Source: CES University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
CES University	Universidad del Valle, Colombia, University of Michigan

Outcome

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