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A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

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ClinicalTrials.gov Identifier: NCT02866929
Recruitment Status : Active, not recruiting
First Posted : August 15, 2016
Last Update Posted : July 20, 2018
Sponsor:
Collaborators:
University of Michigan
Universidad del Valle, Colombia
Information provided by (Responsible Party):
Maria Antonia Alvarez, CES University

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.

Condition or disease Intervention/treatment Phase
Class I Malocclusion Other Periodontal Diseases Thin Gingival Biotype Procedure: Decortication Device: Orthodontics Drug: Mucograft Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Molecular Evaluation of Inflammatory and Bone Remodeling Markers in Gingival Crevicular Fluid After Selective Alveolar Decortication
Study Start Date : September 2016
Actual Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

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
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

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

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




Primary Outcome Measures :
  1. Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement. [ Time Frame: 4 weeks ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Maria Antonia Alvarez, Researcher, CES University
ClinicalTrials.gov Identifier: NCT02866929     History of Changes
Other Study ID Numbers: ODCES001
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Keywords provided by Maria Antonia Alvarez, CES University:
orthodontics
periodontics
piezosurgery
accelerated orthodontics
Surgically Accelerated Orthodontic Treatment

Additional relevant MeSH terms:
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Periodontal Diseases
Malocclusion
Malocclusion, Angle Class I
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases