Status:
UNKNOWN
Short Implants in Edentulous Mandible
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Collaborating Sponsors:
Straumann AG
Conditions:
Tooth Loss
Edentulous Jaw
Eligibility:
All Genders
18-70 years
Brief Summary
Main aim of this study was to assess survival rates of short implants with a length of 4 mm in the edentulous mandible after 1, 3, and 5 years.
Detailed Description
It is hypothesized that survival rates after 1, 3, and 5 years of Straumann Roxolid® / SLActive® 4 mm short implants do not differ from values of Straumann SLActive implants with more than 4 mm length...
Eligibility Criteria
Inclusion
- General criteria:
- Age: 18 to 70
- Edentulous mandible with reduced bone level in the posterior region (\> 5 mm and \< 8 mm above nerve conduit)
- Physical and mental condition that allow surgery and a 5-year follow-up period to be carried out without foreseeable problems
- Obtained informed consent from the patient
- Specific criteria:
- Limited vertical space for implant placement, where conventional implants with lengths of more than 4 mm cannot be used
- Tooth loss or extraction at least 8 weeks before implant surgery
- Healthy implantation site
- Favorable and stable occlusal relationship
- Complete denture in the mandible. If no denture available, an interims prosthesis will be fitted
- Natural full dentition or sufficient complete or partial dentures in the maxilla
Exclusion
- General criteria:
- Any conditions or circumstances which would interfere with the requirements for oral surgery
- Allergy to any metallic implant component
- Acute, untreated periodontitis
- Previous oro-maxillo-facial radiotherapy
- Any disorders in the planned implant area such as previous tumors or chronic bone disease (e.g., rheumatoid disease)
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.)
- Alcohol or drug abuse
- Heavy smoking (\>10 cigarettes/day)
- Uncontrolled diabetes
- Severe bruxism or other destructive oral habits
- Pregnant or lactating women
- Specific criteria:
- Need for a major bone regeneration technique
- Infections in adjacent tissue of the planned implantation site.
- Bleeding on probing (BOP) and plaque index (PI) higher 25%
- Insufficient bone volume in the posterior region for placing a Straumann Roxolid® / SLActive® 4mm short implant and in the interforaminal region for placing a Straumann Roxolid® / SLActive® implant with a minimum length of 10 mm determined by radiographic analysis (OPG)
Key Trial Info
Start Date :
April 19 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04838184
Start Date
April 19 2015
End Date
March 31 2024
Last Update
April 9 2021
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