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A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

Primary Purpose

Class I Malocclusion, Other Periodontal Diseases, Thin Gingival Biotype

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Decortication
Orthodontics
Mucograft
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class I Malocclusion focused on measuring orthodontics, periodontics, piezosurgery, accelerated orthodontics, Surgically Accelerated Orthodontic Treatment

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Arm Label

    Conventional orthodontic treatment

    Orthodontics with decortication

    Orthodontics decortication and Mucograft

    Orthodontics and Mucograft®

    Arm Description

    Patients that will receive conventional orthodontics

    Patients that will receive orthodontic treatment with selective alveolar decortication

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

    Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement.
    Determining the safety and efficacy of the Mucograft by comparing periodontal stability at baseline and post-treatment, taking clinical periodontal measures.
    Measuring tooth movement rate based on changes of tooth alignment using superimposition of digital impressions of the mandibular anterior region of interest.

    Full Information

    First Posted
    July 6, 2016
    Last Updated
    July 18, 2018
    Sponsor
    CES University
    Collaborators
    University of Michigan, Universidad del Valle, Colombia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02866929
    Brief Title
    A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics
    Official Title
    Molecular Evaluation of Inflammatory and Bone Remodeling Markers in Gingival Crevicular Fluid After Selective Alveolar Decortication
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    June 2018 (Actual)
    Study Completion Date
    September 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    CES University
    Collaborators
    University of Michigan, Universidad del Valle, Colombia

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Class I Malocclusion, Other Periodontal Diseases, Thin Gingival Biotype
    Keywords
    orthodontics, periodontics, piezosurgery, accelerated orthodontics, Surgically Accelerated Orthodontic Treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional orthodontic treatment
    Arm Type
    Active Comparator
    Arm Description
    Patients that will receive conventional orthodontics
    Arm Title
    Orthodontics with decortication
    Arm Type
    Experimental
    Arm Description
    Patients that will receive orthodontic treatment with selective alveolar decortication
    Arm Title
    Orthodontics decortication and Mucograft
    Arm Type
    Experimental
    Arm Description
    Orthodontic treatment, selective alveolar decortication and Mucograft® on the mandibular anterior segment
    Arm Title
    Orthodontics and Mucograft®
    Arm Type
    Experimental
    Arm Description
    Patients that will receive orthodontic treatment and Mucograft® on the mandibular anterior segment
    Intervention Type
    Procedure
    Intervention Name(s)
    Decortication
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Orthodontics
    Intervention Description
    Self-ligation brackets in upper and lower teeth
    Intervention Type
    Drug
    Intervention Name(s)
    Mucograft
    Intervention Description
    Porcine naturally cross-linked collagen matrix
    Primary Outcome Measure Information:
    Title
    Volumetric changes of soft tissue in relation to underlying bone using 3D reconstruction models.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Levels of pro-inflammatory cytokines, derived from gingival crevicular fluid, associated with tooth movement.
    Time Frame
    4 weeks
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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

    12. IPD Sharing Statement

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    A Biotype Enhancing Strategy For The Patient Undergoing Accelerated Orthodontics

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