Effect of Alveolar-decortication on Velocity of Tooth Movement

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Birmingham.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mary Alice Bussell, University of Birmingham
ClinicalTrials.gov Identifier:
NCT01093352
First received: March 18, 2010
Last updated: January 15, 2012
Last verified: January 2012
  Purpose

The purpose of this pilot clinical trial is to evaluate whether alveolar-decortication has the potential to reduce orthodontic treatment time following surgical exposure of palatally impacted canines.


Condition Intervention
Palatally Impacted Canines
Procedure: Alveolar-decortication.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Surgical Exposure With Alveolar-decortication vs. Conventional Surgical Exposure to Reduce Treatment Time for Orthodontic Alignment of Palatally Impacted Canines

Resource links provided by NLM:


Further study details as provided by University of Birmingham:

Primary Outcome Measures:
  • Velocity of tooth movement [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]

    The velocity of movement of the canine tooth will be recorded, from the start (buried) position until it is in the line of the arch. Measurements will be taken at each orthodontic appointment, usually 6-8 weeks apart throughtout treatment.

    Distance will be measured with the use of linear measurements, impressions and clinical photographs.



Secondary Outcome Measures:
  • Time for alignment [ Time Frame: approx. 2 years. ] [ Designated as safety issue: No ]
    This will record the overall time for canine alignment, from its initial position to its final position when active orthodontic appliances are removed.

  • Total orthodontic treatment time [ Time Frame: approx. 2.5 years. ] [ Designated as safety issue: No ]
    This will record the overall time, from placement to removal of active orthodontic appliances.

  • Duration of surgery [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The duration of the surgical procedure in minutes, the time inbetween raising and closing the flap of gum tissue will be recorded.

  • Adverse effects of surgery [ Time Frame: approx. 2.5 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard
Standard expose and bond.
Experimental: Alveolar-decortication
Following surgical exposure of the impacted canine, additional perforations will be made in the surrounding cortical bone prior to wound closure.
Procedure: Alveolar-decortication.
Following surgical exposure of the impacted tooth, the surgeon will prepare small holes (perforations) and/or grooves in the cortical bone surrounding the exposed tooth as well as in the buccal bone.
Other Names:
  • Alveolar-decortication
  • Corticotomy assisted orthodontics

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at Birmingham Dental Hospital.
  • Patients with a palatally impacted canine, awaiting surgical exposure.
  • Patients with bilateral impacted canines may be included; in these cases both canines will be treated using the same surgical technique determined by allocation into either the test or control group.
  • Informed consent gained.

Exclusion Criteria:

  • History of periodontal disease.
  • Radiographical evidence of pathology associated with the impacted canine.
  • Patients already participating in a research study.
  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: NCT01093352

Contacts
Contact: Mary Bussell, BDS, MFDS 0121 237 2817 maryalicebussell@hotmail.com
Contact: Thomas Dietrich, DMD, MD, MPH 0121 237 2825 t.dietrich@bham.ac.uk

Locations
United Kingdom
School of Dentistry, University of Birmingham Recruiting
Birmingham, United Kingdom, B4 6NN
Contact: Thomas Dietrich, MPH    0121 237 2825    t.dietrich@bham.ac.uk   
Contact: Mary Bussell, BDS (Bris)    0121 237 2817    mary.bussell@sbpct.nhs.uk   
Principal Investigator: Thomas Dietrich, DMD, MD, MPH         
Sub-Investigator: Mary Bussell, BDS, MFDS         
Sponsors and Collaborators
University of Birmingham
Investigators
Principal Investigator: Thomas Dietrich, DMD, MD, MPH School of Dentistry, University of Birmingham.
  More Information

No publications provided

Responsible Party: Mary Alice Bussell, SpR in orthodontics, University of Birmingham
ClinicalTrials.gov Identifier: NCT01093352     History of Changes
Other Study ID Numbers: 09/H1207/108
Study First Received: March 18, 2010
Last Updated: January 15, 2012
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by University of Birmingham:
Alveolar-decortication
Corticotomy assisted orthodontics
Palatally impacted canine
Surgical exposure of canines
Velocity of tooth movement

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 30, 2014