Status:
ACTIVE_NOT_RECRUITING
Hard and Soft Tissue Maintenance Around Implants With a Sloped Configuration
Lead Sponsor:
Medical University of Graz
Conditions:
Tooth Loss
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study is a controlled, randomized clinical trial over about 16-months (active phase). 40 patients in need of replacement of a single tooth with a minimal crestal bone width of 4 - 5mm and suitabl...
Detailed Description
Digital scans will be done at first, 5th, 6th, 8th, and 10th visit to get the possibility to determine and compare volume changing and stability at augmented or not augmented implant sites during foll...
Eligibility Criteria
Inclusion
- Written consent after clarification
- capability of giving an informed consent
- good health as defined by the subjects medical history (no contraindications as described in the exclusion criteria below)
- age 18 years of age and over
- Good periodontal status: BOP \< 20%, PI \< 30%, no PD \> 4mm
- No heavy smokers (\< 10 cigarettes/day)
- At least 1 missing tooth in the premolar and molar region (in selected cases in the frontal area) either in the maxilla or in the mandible requiring implant therapy for reconstruction.
- implant site must present a buccal bone defect not extending a lingual-buccal or buccal-palatinal height discrepancy of 5mm and a sufficient bone width for simultaneously GBR procedure
- implant site must present at least a neighbouring tooth on its mesial aspect
Exclusion
- Insufficient bone volume for implant placement requiring a sinus floor elevation or extensive bone augmentation
- Heavy Smokers (\>10 cigarettes/day)
- Medication with a contraindication for implant therapy
- Skeletal immaturity
- Any active malignancy or ongoing treatment for malignancy
- An active infection at the operative site
- Contraindications to the class of drugs which are used at regular surgical procedures, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, except penicillin-allergy
- Pregnancy
- unable or unwilling to return for follow-up visits for a period of at least 16 months
Key Trial Info
Start Date :
January 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04712565
Start Date
January 14 2021
End Date
November 30 2025
Last Update
November 20 2024
Active Locations (1)
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1
Medical Universtiy Graz
Graz, Austria, 8010