The Regulation of Osteoprotegerin by Mechanical Stimulation - Tabular View

Tracking Information

First Received Date ^ICMJE

September 8, 2005

Last Updated Date

November 25, 2005

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Tissue staining of antibody

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00155311 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

The Regulation of Osteoprotegerin by Mechanical Stimulation

Official Title ^ICMJE

Brief Summary

To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.

Detailed Description

Long treatment time is a major factor causing high fee for orthodontic treatment. Patients would have dental caries or periodontitis resulted from improper oral hygiene care during this long treatment period. Therefore, how to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on tooth induces bone resorption on the compression side and bone deposition on the tension side, thus bone remodels and then tooth moves. Bone resorption is a complex process. Osteoblasts play an important role during initiation of bone resorption.

Changes OPG expression of osteoblasts under mechanical stimulation can play a role in bone remodeling. In order to test this hypothesis, the following specific aims will be achieved:

To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
To optimize the regulation by changing magnitude and frequency of pressure, and characterize the time table for these changes..

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Single Blind, Active Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Malocclusion

Intervention ^ICMJE

Procedure: orthodontic treatment

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

patients with two mandibular impaction third molars containing at least one mesially angular impaction with crown exposed to the oral cavity

Exclusion Criteria:

pregnancy or diseases with abnormal bone metabolism

Gender

Both

Ages

18 Years to 35 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Chung-Chen Yao, DDS, PhD

886-2-23123456 ext 7689

janeyao@ha.mc.ntu.edu.tw

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT ID ^ICMJE

NCT00155311

Responsible Party

Study ID Numbers ^ICMJE

9361700741

Study Sponsor ^ICMJE

National Taiwan University Hospital

Collaborators ^ICMJE

National Science Council, Taiwan

Investigators ^ICMJE

Principal Investigator:

Chung-Chen Yao, DDS, PhD

National Taiwan University Hospital

Information Provided By

National Taiwan University Hospital

Verification Date

June 2004

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP