NCT00172718

Brief Summary

Osseointegrated root form implants have been applied successfully in treating fully and partially edentulous patients and patients with single tooth missing. However, the success rate of osseointegrated dental implants was not as good in patients with poor bone quality. The reasons are believed that poor bone quality reduces the initial stability of dental implants and then reduces the success rate. For increasing initial stability of dental implants, some technical modifications are suggested in literature. However, due to lack of an objective method to evaluate bone quality, they are controversial. The purposes of this clinical study are to develop a standard procedure which using cutting resistance measured by Osseocare in surgery to evaluate the bone quality and to compare with the clinical experiences of oral surgeons. The objective outcome, initial stability of dental implant, is measured with Osstell. The analyzed results are also helpful for less experienced surgeons.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

June 6, 2008

Status Verified

February 1, 2005

First QC Date

September 12, 2005

Last Update Submit

June 5, 2008

Conditions

Jaw, Edentulous, PartiallyMouth, Edentulous

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No major systemic diseases
  • Mouth opening: \> 35 mm
  • Missing teeth at anterior or premolar area and willing to restored by implantation

You may not qualify if:

  • Uncomfortable or other condition occurring in the surgical procedure make the measuring unacceptable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Dentistry, National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Jaw, Edentulous, PartiallyMouth, Edentulous

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth DiseasesTooth Diseases

Study Officials

  • Tong-Mei Wang, DDS, MS

    National Taiwan University, School of Dentistry

    PRINCIPAL INVESTIGATOR

  • Li-Deh Lin, DDS, PhD

    National Taiwan University, School of Dentistry

    STUDY DIRECTOR

Central Study Contacts

Tong-Mei Wang, DDS, MS

CONTACT

886-2-23123456tongmei@ha.mc.ntu.edu.tw

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 15, 2005

Study Start

March 1, 2005

Last Updated

June 6, 2008

Record last verified: 2005-02

Locations

TW(1)