A Phase 4 interventional study of Decortication and Orthodontics in Class I Malocclusion, Other Periodontal Diseases and Thin Gingival Biotype, sponsored by CES University. Status unknown. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by CES University · Phase 4, Interventional, and Treatment
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.
35 studies on the registry are indexed under Malocclusion, Angle Class I; 10 are open to participants now.
This study's enrollment of 40 is above the median of 32 across 31 interventional studies indexed under Malocclusion, Angle Class I.
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Exclusion Criteria:
Patient with presence of marginal tissue recessions on inferior incisors
Patients that will receive conventional orthodontics
Device: Orthodontics
Patients that will receive orthodontic treatment with selective alveolar decortication
Procedure: Decortication · Device: Orthodontics
Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment
Procedure: Decortication · Device: Orthodontics · Drug: Mucograft
Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment
Device: Orthodontics · Drug: Mucograft
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.
Self-ligation brackets in upper and lower teeth
Porcine naturally cross-linked collagen matrix
Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models.
Time frame: 2 years
Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement.
Time frame: 4 weeks
Determining the safety and efficacy of the Mucograft by comparing periodontal stability at baseline and post-treatment, taking clinical periodontal measures.
Time frame: 2 years
Measuring tooth movement rate based on changes of tooth alignment using superimposition of digital impressions of the mandibular anterior region of interest.
Time frame: 2 years
No study locations are listed for this record.
The record gives a start of Sep 2016, a primary completion of Jun 2018 and a completion of Sep 2018. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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CES University