search
Back to results

Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment

Primary Purpose

Orthodontic Malocclusion

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgically facilitated Orthodontic treatment
Conventional orthodontic treatment
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontic Malocclusion focused on measuring orthodontics, Tooth Movement, Bone Remodeling, Mandible, Osteotomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth.

Exclusion Criteria:

  • Bone-related diseases
  • Previous or current use of biphosphate therapy
  • Previous mucogingival surgery in the area

  • Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate

    - History of previous orthodontic treatment less than 4 years ago

  • Smoking >10 cigarettes/day )
  • Medical history that contraindicates surgical treatment,
  • People who are not cognitively able to give consent,
  • Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional orthodontic treatment

    Surgically facilitated Orthodontics

    Arm Description

    conventional orthodontic treatment in the mandibular anterior region

    Surgically facilitated Orthodontic treatment in the mandibular anterior region

    Outcomes

    Primary Outcome Measures

    Rate of orthodontic tooth movement
    Difference between the rate of orthodontic tooth movement between the two groups as measured by linear measurements on digitized study casts obtained at 4-week intervals.

    Secondary Outcome Measures

    Incidence of mucogingival defects
    Incidence of mucogingival defects as clinically measured by gingival recession (GR), clinical attachment level (CAL), probing depth (PD), width of keratinized tissue (WKT) and biotype), by a calibrated examiner
    Incidence and magnitude of apical root resorption
    Incidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs)

    Full Information

    First Posted
    May 28, 2013
    Last Updated
    October 30, 2019
    Sponsor
    University of Minnesota
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01866345
    Brief Title
    Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment
    Official Title
    Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Cannot find subjects to particpate
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Minnesota

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this investigation is intended to evaluate the efficacy of surgically facilitated orthodontic treatment (SFO) in terms of treatment time, incidence of root shortening, and occurrence of mucogingival side effects compared to conventional orthodontic therapy in patients undergoing orthodontic treatment to correct crowding and/or retroclination of their mandibular anterior dentition.
    Detailed Description
    The null-hypothesis for this research project is that there will be no difference in the rate of orthodontic movement among patients requiring proclination or alignment of their mandibular anterior teeth with SFO (TEST group) as compared to conventional orthodontic treatment (CONTROL group). A null-hypothesis is that there will be no difference between both treatment groups in the occurrence of dental (root shortening) or periodontal (mucogingival defects, alveolar bone resorption) complications associated with orthodontic treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthodontic Malocclusion
    Keywords
    orthodontics, Tooth Movement, Bone Remodeling, Mandible, Osteotomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional orthodontic treatment
    Arm Type
    Active Comparator
    Arm Description
    conventional orthodontic treatment in the mandibular anterior region
    Arm Title
    Surgically facilitated Orthodontics
    Arm Type
    Experimental
    Arm Description
    Surgically facilitated Orthodontic treatment in the mandibular anterior region
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgically facilitated Orthodontic treatment
    Intervention Description
    Surgically facilitated Orthodontic treatment in the mandibular anterior region
    Intervention Type
    Procedure
    Intervention Name(s)
    Conventional orthodontic treatment
    Intervention Description
    Conventional orthodontic Procedure
    Primary Outcome Measure Information:
    Title
    Rate of orthodontic tooth movement
    Description
    Difference between the rate of orthodontic tooth movement between the two groups as measured by linear measurements on digitized study casts obtained at 4-week intervals.
    Time Frame
    6 months(plus or minus 1 week)
    Secondary Outcome Measure Information:
    Title
    Incidence of mucogingival defects
    Description
    Incidence of mucogingival defects as clinically measured by gingival recession (GR), clinical attachment level (CAL), probing depth (PD), width of keratinized tissue (WKT) and biotype), by a calibrated examiner
    Time Frame
    6 months(plus or minus 2weeks) after initiation of treatment
    Title
    Incidence and magnitude of apical root resorption
    Description
    Incidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs)
    Time Frame
    6(plus or minus 1) months following initiation of treatment
    Other Pre-specified Outcome Measures:
    Title
    Thickness and height of the buccal and lingual bony plates
    Description
    Thickness and height of the buccal and lingual bony plates will be measured from pre- and post-treatment Cone beam volumetric tomograms
    Time Frame
    6(plus or minus 1) months following initiation of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: -Adults (18-65 y.o.) who seek orthodontic treatment for proclination and/or de-crowding of mandibular anterior teeth. Exclusion Criteria: Bone-related diseases Previous or current use of biphosphate therapy Previous mucogingival surgery in the area Genetic syndromes, craniofacial anomalies, or cleft lip and/or palate - History of previous orthodontic treatment less than 4 years ago Smoking >10 cigarettes/day ) Medical history that contraindicates surgical treatment, People who are not cognitively able to give consent, Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Georgios A Kotsakis, DDS
    Organizational Affiliation
    Dental Fellow
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19761909
    Citation
    Murphy KG, Wilcko MT, Wilcko WM, Ferguson DJ. Periodontal accelerated osteogenic orthodontics: a description of the surgical technique. J Oral Maxillofac Surg. 2009 Oct;67(10):2160-6. doi: 10.1016/j.joms.2009.04.124. No abstract available.
    Results Reference
    background
    PubMed Identifier
    18771369
    Citation
    Sebaoun JD, Kantarci A, Turner JW, Carvalho RS, Van Dyke TE, Ferguson DJ. Modeling of trabecular bone and lamina dura following selective alveolar decortication in rats. J Periodontol. 2008 Sep;79(9):1679-88. doi: 10.1902/jop.2008.080024.
    Results Reference
    background

    Learn more about this trial

    Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment

    We'll reach out to this number within 24 hrs