Dental Implant, Dental Restoration, Edentulous Alveolar Ridge, Implant-supported Fixed Prosthesis
Conditions
Keywords
nanostructured-implant, titanium implant, nano-roughness surface, hydrophilic surface, KONTACT N, BIOTECH DENTAL
Brief summary
A multicenter prospective observational study in which aim is to illustrate the clinical outcome of dental implants Kontact N; and the effects of its nanostructured surface on the osseointegration and secondary stability without increasing the rate of peri-implantitis. 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
DEVICEdental implant (KONTACT N)
Implant-supported prosthetic restoration
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 * Non-opposition of the patient for the collection of his medical data as part of the study (delivery of a patient's sheet)
Exclusion criteria
1. Poor oral hygiene 2. Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints 3. Infections and oral inflammation such as periodontitis, gingivitis 4. Patient with metabolic disorders (eg diabetes mellitus) or bone disease that may compromise peri-implant tissue healing 5. Heavy smoker (\> 10 cigarettes / day) 6. Patient with a pathology or immunosuppressive therapy such as chemotherapy, radiotherapy 7. Patient on prolonged steroid therapy 8. Titanium / titanium alloy allergy 9. Alcohol or drug abuse 10. Pregnant woman (or likely to be pregnant); or breastfeeding 11. Difficulty of medical follow-up patients with geographical, social or psychological constraints 12. Persons deprived of liberty or guardianship 13. Involuntary / patient refusal to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant success rate | up to 12 months post-implantation | Rate of implants still in function up to 12 months post-implantation and which fulfill all the predefined success criteria in the protocol. |
| Peri-implantitis rate | 12 months post-implantation | Peri-implantitis is an inflammatory process affecting the tissues around the implant and causing loss of bone support (diagnosed by radiographic and clinical assessment). |
| Mean osseointegration period | From the implantation up to 12 months | Period from which a direct structural and functional junction can be observed between the remodeled living bone and the implant surface (by clinical and radiographic assessment). |
Countries
France
Outcome results
None listed