Effect of Alveolar-decortication on Velocity of Tooth Movement
The Efficacy of Surgical Exposure With Alveolar-decortication vs. Conventional Surgical Exposure to Reduce Treatment Time for Orthodontic Alignment of Palatally Impacted Canines
1 other identifier
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2010
CompletedFirst Submitted
Initial submission to the registry
March 18, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 25, 2017
CompletedOctober 11, 2018
October 1, 2018
5 years
March 18, 2010
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Velocity of tooth movement
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.
6-8 weeks
Secondary Outcomes (4)
Time for alignment
approx. 2 years.
Total orthodontic treatment time
approx. 2.5 years.
Duration of surgery
1 day
Adverse effects of surgery
approx. 2.5 years.
Study Arms (2)
Standard
NO INTERVENTIONStandard expose and bond.
Alveolar-decortication
EXPERIMENTALFollowing surgical exposure of the impacted canine, additional perforations will be made in the surrounding cortical bone prior to wound closure.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- History of periodontal disease.
- Radiographical evidence of pathology associated with the impacted canine.
- Patients already participating in a research study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Dentistry, University of Birmingham
Birmingham, B4 6NN, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Dietrich, DMD, MD, MPH
School of Dentistry, University of Birmingham.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- SpR in orthodontics
Study Record Dates
First Submitted
March 18, 2010
First Posted
March 25, 2010
Study Start
February 23, 2010
Primary Completion
March 1, 2015
Study Completion
October 25, 2017
Last Updated
October 11, 2018
Record last verified: 2018-10