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Clinical Trials/NCT04838184
NCT04838184
Unknown
Not Applicable

Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible

Universitätsklinikum Hamburg-Eppendorf0 sites20 target enrollmentApril 19, 2015
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ConditionsTooth LossEdentulous Jaw

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tooth Loss
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Enrollment
20
Primary Endpoint
Survival
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

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 in the same clinical situation.

Registry
clinicaltrials.gov
Start Date
April 19, 2015
End Date
March 31, 2024
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Survival

Time Frame: 5 years

Survival of implants and suprastructure. Measure: survival rates

Secondary Outcomes

  • Implant stability(3 months)
  • Patient satisfaction(5 years)
  • Success(5 years)
  • Oral health-related quality of life(5 years)

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