Effect of Corticotomy on the Orthodontic Tooth Movement

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Universidad de Antioquia
Sponsor:
Information provided by (Responsible Party):
Javier Enrique Botero, Universidad de Antioquia
ClinicalTrials.gov Identifier:
NCT01630473
First received: June 24, 2012
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

Orthodontic therapy allows for the treatment of dental malpositions in order to produce an adequate relationship between teeth during occlusion. Conventional orthodontic therapy applies slight forces and moves teeth slowly. It is generally performed during a 2 year minimum of time. Recent studies seem to suggest that orthodontic therapy time can be shortened by surgical assistance (corticotomy). 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.


Condition Intervention
Tooth Crowding
Procedure: Corticotomy
Procedure: Conventional orthodontics

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Comparison Between the Corticotomy-assisted Orthodontics and Conventional Orthodontics

Resource links provided by NLM:


Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Corticotomy-assisted orthodontics
This group of patients will receive corticotomy surgical procedure at day 0. Orthodontic activation will start immediately after surgery.
Procedure: Corticotomy
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 Name: Osteotomy
Active Comparator: Conventional orthodontics
This group of patients will receive conventional orthodontics starting at day 0.
Procedure: Conventional orthodontics
Conventional orthodontic treatment
Other Name: Orthodontic 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.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT01630473

Contacts
Contact: Javier E Botero, PhD 057-4-219 6719 drjavo@yahoo.com

Locations
Colombia
Faculty of Dentistry, Universidad de Antioquia Recruiting
Medellin, Antioquia, Colombia, 00000
Contact: Javier E Botero, PhD    057-4-219 6719    drjavo@yahoo.com   
Principal Investigator: Juan D Arango, DDS         
Sub-Investigator: David Arango, DDS         
Sub-Investigator: Alejandro Sanchez, DDS         
Sub-Investigator: Mauricio Villegas, DDS         
Sponsors and Collaborators
Universidad de Antioquia
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
  More Information

Publications:
Responsible Party: Javier Enrique Botero, Full Time Professor of Periodontics, Universidad de Antioquia
ClinicalTrials.gov Identifier: NCT01630473     History of Changes
Other Study ID Numbers: CORT2011
Study First Received: June 24, 2012
Last Updated: May 28, 2013
Health Authority: Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:
Tooth crowding
Teeth malpositions
corticotomy
orthodontics
tooth movement
periodontal parameters

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 22, 2014