- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01630473
Effect of Corticotomy on the Orthodontic Tooth Movement
Clinical Comparison Between the Corticotomy-assisted Orthodontics and Conventional Orthodontics
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The use of surgical techniques to accelerate orthodontic tooth movement has been developed. By means of surgical burs, vertical grooves in the cortical plate (corticotomy) are produced mesial and distal to the roots of teeth that are being moved 3 mm below the marginal crest and extending beyond the apex. Animal studies showed that the rapid orthodontic tooth movement was due to increased cellular activity in the surrounding periodontal tissues, a regional acceleratory phenomenon (RAP). A high osteoclastic activity is observed in the compression side although is also observed in the tension side to a less degree. Histological analysis indicates that at day 21 the remodeling tissues are replaced by a fibrous tissue and later (60 days) by bone. Furthermore, the tissues immediately adjacent to the corticotomy are characterized by an increased width of the periodontal ligament, less calcified spongiosa bone surface and higher counts of osteoclasts. But not only the catabolic activity is increased (osteoclasts) but also the anabolic activity (osteoblasts) is increased 3-fold as well. This balances the rate of bone resorption and bone apposition. An interesting finding was the reduced rate of hyalinization at the compression site, which may be due to increased width of the periodontal ligament and thus facilitating tooth movement.
As opposed to conventional osteotomy used in alveolar distraction, the preservation of the medullar vasculature during a corticotomy procedure provides and adequate blood supply and nutrition. This accelerates the rate of tissue healing and remodeling and hence orthodontic movement can start immediately after surgery. It has been calculated that the rate of tooth movement is doubled (2.5mm to 3mm at day 25) in comparison to standard orthodontics without any detrimental effects on periodontal tissues. This surgically assisted approach for improved tooth movement is beneficial for molar intrusion, space closure, de-crowding and open bite management.
This investigation is aimed to determine the velocity of tooth movement and changes in periodontal clinical parameters between corticotomy-assisted orthodontic therapy and conventional orthodontic therapy. Periodontally and systemically healthy subjects in need of orthodontic therapy for the treatment of teeth crowding in the anterior segment. The rate of tooth movement will be assessed by radiographs and cast models and periodontal clinical parameters will be recorded at each visit during the 4 month follow-up.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Antioquia
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Medellin, Antioquia, Colombia, 00000
- Faculty of Dentistry, Universidad de Antioquia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Voluntary participation
- Legally adult age (>18 years old)
- Full permanent dentition (28 teeth excluding third molars)
- Severe anterior teeth crowding
- Thick periodontal biotype
Exclusion Criteria:
- Systemic diseases (i.e. diabetes, HIV)
- cigarette smoking
- Under medications: bisphosphonates, anti-epileptic drugs, contraceptives, corticosteroids, estrogen, antihistamine drugs, calcitonin, vitamin D
- Previous orthodontic treatment
- Periodontal disease
- Severe gingival recessions
- Pregnancy
- Previous root resorption
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Corticotomy-assisted orthodontics
This group of patients will receive corticotomy surgical procedure at day 0. Orthodontic activation will start immediately after surgery.
|
After a periodontal full flap is dissected, by using small round burs, vertical lines (2 mm depth corticotomy) parallel to each root of the teeth in the anterior segment (canines and incisors) are created 5 mm beyond the apex in the maxillary bones and interconnecting the lines at the apex by horizontal corticotomies.
Marginal bone crest is not touched by the surgical procedure.
Other Names:
|
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Active Comparator: Conventional orthodontics
This group of patients will receive conventional orthodontics starting at day 0.
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Conventional orthodontic treatment
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in tooth position
Time Frame: 0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
|
0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Periodontal Clinical Parameters
Time Frame: 0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
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0 days, 7 days, 15 days, 1st month, 2nd month, 3rd month and 4th month after surgery and conventional orthodontic
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juan D Arango, DDS, Faculty of Dentistry, Universidad de Antioquia
- Study Director: Javier E Botero, PhD, Faculty of Dentistry, Universidad de Antioquia
Publications and helpful links
General Publications
- Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19.
- Nowzari H, Yorita FK, Chang HC. Periodontally accelerated osteogenic orthodontics combined with autogenous bone grafting. Compend Contin Educ Dent. 2008 May;29(4):200-6; quiz 207, 218.
- Ozturk M, Doruk C, Ozec I, Polat S, Babacan H, Bicakci AA. Pulpal blood flow: effects of corticotomy and midline osteotomy in surgically assisted rapid palatal expansion. J Craniomaxillofac Surg. 2003 Apr;31(2):97-100. doi: 10.1016/s1010-5182(02)00188-9.
- Koudstaal MJ, Wolvius EB, Schulten AJ, Hop WC, van der Wal KG. Stability, tipping and relapse of bone-borne versus tooth-borne surgically assisted rapid maxillary expansion; a prospective randomized patient trial. Int J Oral Maxillofac Surg. 2009 Apr;38(4):308-15. doi: 10.1016/j.ijom.2009.02.012. Epub 2009 Mar 10.
- Akay MC, Aras A, Gunbay T, Akyalcin S, Koyuncue BO. Enhanced effect of combined treatment with corticotomy and skeletal anchorage in open bite correction. J Oral Maxillofac Surg. 2009 Mar;67(3):563-9. doi: 10.1016/j.joms.2008.06.091.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CORT2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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