Effect of Alveolar-decortication on Velocity of Tooth Movement
Recruitment status was Recruiting
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.
|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|
- 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.
- 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 ]
|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)|
No Intervention: Standard
Standard expose and bond.
Following surgical exposure of the impacted canine, additional perforations will be made in the surrounding cortical bone prior to wound closure.
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01093352
|Contact: Mary Bussell, BDS, MFDS||0121 237 firstname.lastname@example.org|
|Contact: Thomas Dietrich, DMD, MD, MPH||0121 237 email@example.com|
|School of Dentistry, University of Birmingham||Recruiting|
|Birmingham, United Kingdom, B4 6NN|
|Contact: Thomas Dietrich, MPH 0121 237 2825 firstname.lastname@example.org|
|Contact: Mary Bussell, BDS (Bris) 0121 237 2817 email@example.com|
|Principal Investigator: Thomas Dietrich, DMD, MD, MPH|
|Sub-Investigator: Mary Bussell, BDS, MFDS|
|Principal Investigator:||Thomas Dietrich, DMD, MD, MPH||School of Dentistry, University of Birmingham.|