Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dentistry
- Sponsor
- Biotech Dental
- Enrollment
- 159
- Locations
- 1
- Primary Endpoint
- Peri implant bone level
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.
All the enrolled patients will be eligible for one or multiple implant-supported fixed restoration(s) according to the routine clinical practice and the manufacturer's instruction for use.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Edentulous patient (partially or completely AND formerly, recently or just before implantation) requiring the placement of one (or more) dental implant (s) in maxillary or mandibular
- •Age ≥ 18 years
- •Good general health (ASA score between \[1-2\])
- •Sufficient bone volume and quality (with or without bone graft) to support the implant
- •Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet)
Exclusion Criteria
- •Poor oral hygiene
- •Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
- •Infections and oral inflammation such as periodontitis, gingivitis
- •Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing
- •Heavy smoker (\> 10 cigarettes / day)
- •Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy
- •Patient on prolonged steroid therapy
- •Titanium / titanium alloy allergy
- •Alcohol or drug abuse
- •Pregnant woman (or likely to be pregnant); or breastfeeding
Outcomes
Primary Outcomes
Peri implant bone level
Time Frame: up to 36 months
Bone level evolution compare to the bone level at implantation day
Keratinized tissues level
Time Frame: up to 36 months
Assessment of keratinized tissues
Gingival index
Time Frame: up to 36 months
Gingival index assess with Loë and Silness Score
Implant survival rate
Time Frame: up to 36 months
Number of implants still in function up to 36 months post implantation
Bleeding index
Time Frame: up to 36 months
Bleeding index on probing following the Mombelli score