Clinical trial NCT03543618: Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Official title: Evaluation of Dental Implant Placement in the Sloped Alveolar Ridge
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrophy of Edentulous Alveolar Ridge
Keywords: dental implant
edentulous ridge
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 20-80 years old with appropriate oral cleaning ability; the computer tomography shows \> 1 mm buccolingual discrepancy of alveolar ridge height; no generalized periodontitis, or had history of periodontitis but has been completed treatment; no major systemic infection or major systemic illness; not taken antibiotics in the past two weeks Not pregnant or breastfeeding

Primary outcomes:
measure: Clinical assessment of the status of osseointegration
timeFrame: up to 3 years
Secondary outcomes:
measure: The health status of adjacent teeth
timeFrame: 0 day, 6 months, 1 year, 2 years, 3 years
measure: The peri-implant health
timeFrame: 1 year, 2 years, 3 years
measure: Biomarkers in the gingival crevicular fluid of adjacent teeth
timeFrame: 0 day, 6 months, 1 year, 2 years, 3 years
measure: Biomarkers in the gingival crevicular fluid of dental implant
timeFrame: 1 year, 2 years, 3 years
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Po-Chun Chang
role: PRINCIPAL_INVESTIGATOR
References: