Clinical trial NCT03582657: Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"
Official title: Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implant
Dental Restoration
Edentulous Alveolar Ridge
Implant-supported Fixed Prosthesis
Keywords: nanostructured-implant
titanium implant
nano-roughness surface
hydrophilic surface
KONTACT N
BIOTECH DENTAL
Lead sponsor: Biotech Dental
Sponsor class: INDUSTRY
First posted: 2018-07-11
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient who is eligible and planned for an implant-supported prosthetic restoration following the instructions for use of the KONTACT N implant and who meets the inclusion / exclusion criteria.

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.


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
* 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

Primary outcomes:
measure: Implant success rate
timeFrame: up to 12 months post-implantation
measure: Peri-implantitis rate
timeFrame: 12 months post-implantation
measure: Mean osseointegration period
timeFrame: From the implantation up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Dr KHOURY Elias
Study officials:
name: KHOURY, Dr
role: PRINCIPAL_INVESTIGATOR
References: