Clinical trial NCT04838184: Short Implants in Edentulous Mandible
Official title: Prospective Clinical Study of Straumann Roxolid®/SLactive® Short Implants in Edentulous Mandible
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tooth Loss
Edentulous Jaw
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: Straumann AG
First posted: 2021-04-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Dental patients of university-based prosthodontic department (primary, secondary, and tertiary care clinic)

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.

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
* 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 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
* 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)

Primary outcomes:
measure: Survival
timeFrame: 5 years
Secondary outcomes:
measure: Implant stability
timeFrame: 3 months
measure: Success
timeFrame: 5 years
measure: Oral health-related quality of life
timeFrame: 5 years
measure: Patient satisfaction
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References: