Trial record 2 of 5 for:
Open Studies | "Tooth, Impacted"
Effect of Alveolar-decortication on Velocity of Tooth Movement
This study is currently recruiting participants.
Verified January 2012 by University of Birmingham
Sponsor:
University of Birmingham
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
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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:
|
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
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 May 23, 2013