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

This study has been withdrawn prior to enrollment.
(Cannot find subjects to particpate)
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01866345
First received: May 28, 2013
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Orthodontic Malocclusion
Procedure: Surgically facilitated Orthodontic treatment
Procedure: Conventional orthodontic treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Blinded, Controlled Clinical Trial of Surgically Facilitated Orthodontic Treatment in the Mandibular Anterior Region

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Rate of orthodontic tooth movement [ Time Frame: 6 months(plus or minus 1 week) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months(plus or minus 2weeks) after initiation of treatment ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6(plus or minus 1) months following initiation of treatment ] [ Designated as safety issue: Yes ]
    Incidence and magnitude of apical root resorption will be estimated from pre- and post-treatment cone-beam computed tomograms (CBCTs)


Other Outcome Measures:
  • Thickness and height of the buccal and lingual bony plates [ Time Frame: 6(plus or minus 1) months following initiation of treatment ] [ Designated as safety issue: No ]
    Thickness and height of the buccal and lingual bony plates will be measured from pre- and post-treatment Cone beam volumetric tomograms


Enrollment: 0
Study Start Date: August 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional orthodontic treatment
conventional orthodontic treatment in the mandibular anterior region
Procedure: Conventional orthodontic treatment
Conventional orthodontic Procedure
Experimental: Surgically facilitated Orthodontics
Surgically facilitated Orthodontic treatment in the mandibular anterior region
Procedure: Surgically facilitated Orthodontic treatment
Surgically facilitated Orthodontic treatment in the mandibular anterior region

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01866345

Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Georgios A Kotsakis, DDS Dental Fellow
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01866345     History of Changes
Other Study ID Numbers: 001
Study First Received: May 28, 2013
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
orthodontics
Tooth Movement
Bone Remodeling
Mandible
Osteotomy

Additional relevant MeSH terms:
Malocclusion
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 21, 2014