Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Clinical assessment of the status of osseointegration
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Control
Installation of conventional design dental implant
Intervention: Control (Device)
Sloped
Installation of sloped design dental implant
Intervention: Sloped (Device)
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)