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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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02866929
Enrollment
40
Registered
2016-08-15
Start date
2016-09-30
Completion date
2018-09-30
Last updated
2018-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Class I Malocclusion, Other Periodontal Diseases, Thin Gingival Biotype

Keywords

orthodontics, periodontics, piezosurgery, accelerated orthodontics, Surgically Accelerated Orthodontic 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.

Interventions

PROCEDUREDecortication

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.

DEVICEOrthodontics

Self-ligation brackets in upper and lower teeth

Porcine naturally cross-linked collagen matrix

Sponsors

University of Michigan
CollaboratorOTHER
Universidad del Valle, Colombia
CollaboratorOTHER
CES University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models.2 years

Secondary

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026