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The Regulation of Osteoprotegerin by Mechanical Stimulation

Primary Purpose

Malocclusion

Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
orthodontic treatment
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring orthodontic tooth movement, OPG, RANKL

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Dentistry, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

days after treatment

Arm Description

different days after orthodontic treament, samples will be taken.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
March 14, 2013
Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT00155311
Brief Title
The Regulation of Osteoprotegerin by Mechanical Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
orthodontic tooth movement, OPG, RANKL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
days after treatment
Arm Type
Experimental
Arm Description
different days after orthodontic treament, samples will be taken.
Intervention Type
Procedure
Intervention Name(s)
orthodontic treatment
Primary Outcome Measure Information:
Title
OPG staining
Description
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.
Time Frame
at most 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chung-Chen Yao, DDS, PhD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dentistry, National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

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The Regulation of Osteoprotegerin by Mechanical Stimulation

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