Dental Implant, Dental Restoration, Dentistry, Implant-supported Fixed Prosthesis
Conditions
Keywords
Mono Block design, KONTACT MB, Biotech Dental
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.
Interventions
DEVICEKONTACT MB
Dental implant surgery
Sponsors
Biotech Dental
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 * Difficulty of medical follow-up patients with geographical, social or psychological constraints * Persons deprived of liberty or guardianship * Involuntary / patient refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant survival rate | up to 36 months | Number of implants still in function up to 36 months post implantation |
| Peri implant bone level | up to 36 months | Bone level evolution compare to the bone level at implantation day |
| Keratinized tissues level | up to 36 months | Assessment of keratinized tissues |
| Gingival index | up to 36 months | Gingival index assess with Loë and Silness Score |
| Bleeding index | up to 36 months | Bleeding index on probing following the Mombelli score |
Countries
France
Contacts
Primary ContactCécile Reynès
Backup ContactPascal Breysse
Outcome results
None listed