Skip to main content
Clinical Trials/NCT03543618
NCT03543618
Unknown
Not Applicable

Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge

National Taiwan University Hospital1 site in 1 country40 target enrollmentMarch 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Atrophy of Edentulous Alveolar Ridge
Sponsor
National Taiwan University Hospital
Enrollment
40
Locations
1
Primary Endpoint
Clinical assessment of the status of osseointegration
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study was to investigate the therapeutic effect of sloped dental implants. It can reduce the need of osteoectomy, reduce discomfort of procedures, and is easier for maintenance.

Detailed Description

20 OsseoSpeed ™ Profile EV and 20 OsseoSpeed ™ EV groups will be randomly implanted into the oblique edentulous ridges of subjects, and the treatment response will be monitored for 3 years. The implantation area will be randomly divided into two groups, One group was treated with OsseoSpeed ™ Profile EV (sloped group) and the other group was treated with OsseoSpeed ™ EV (control group). The same patient had the same implant as the same quadrant. The patient will be followed up regularly for follow-up, followed by clinical attachment level, probing depth, bleeding on probing, keratinized gingival width (Keratinized gingiva), mobility (mobility) and other clinical indicators of the measurement, regular dental radiography, gingival crevicular fluid (GCF) collection and bone integration measurement. After six months of implantation, prosthesis will delivered and loaded functionally, and regular follow-up will be arranged. In each time of follow-up, examination will be carried out with regards to periodontal pocket depth, clinical attachment height, periodontal bleeding index, keratinized gingival width, and other clinical indicators of the measurement, at the end of the experiment, that is, after three years, and then a dental root film irradiation, GCF collection and osseointegration measurement.

Registry
clinicaltrials.gov
Start Date
March 15, 2018
End Date
July 31, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Clinical assessment of the status of osseointegration

Time Frame: up to 3 years

radiographic bone level, bone consolidation index (ISQ)

Secondary Outcomes

  • The peri-implant health(1 year, 2 years, 3 years)
  • The health status of adjacent teeth(0 day, 6 months, 1 year, 2 years, 3 years)
  • Biomarkers in the gingival crevicular fluid of adjacent teeth(0 day, 6 months, 1 year, 2 years, 3 years)
  • Biomarkers in the gingival crevicular fluid of dental implant(1 year, 2 years, 3 years)

Study Sites (1)

Loading locations...

Similar Trials