The Regulation of Osteoprotegerin by Mechanical Stimulation

Malocclusion Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00155311
• Other study ID #: 9361700741
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2005
• Last updated: March 14, 2013
• Start date: January 2005

Study information

• Verified date: March 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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:

1. 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.

2. To optimize the regulation by changing magnitude and frequency of pressure, and characterize the time table for these changes..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malocclusion

Intervention

Procedure:
• orthodontic treatment

Locations

Country	Name	City	State
Taiwan	Department of Dentistry, National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OPG staining	at 1, 3, 7 days after orthodontic force application on wisdom teeth, bone covering the tooth will be removed before taking the wisdom tooth out. The tissue section of the bone will be done with immunocytochemistry after de-calicification.	at most 7 days	No