Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"

Dental Implant Clinical Trial

Official title:

Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03582657
• Other study ID #: 2018-A00194-51
• Status: Completed
• Start date: February 4, 2019
• Est. completion date: January 13, 2022

Study information

• Verified date: March 2022
• Source: Biotech Dental
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: January 13, 2022
• Est. primary completion date: September 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant
• Dental Restoration
• Edentulous Alveolar Ridge
• Implant-supported Fixed Prosthesis
• Mouth, Edentulous

Intervention

Device:
• dental implant (KONTACT N)
Implant-supported prosthetic restoration

Locations

Country	Name	City	State
France	Dr KHOURY Elias	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Dental

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant success rate	Rate of implants still in function up to 12 months post-implantation and which fulfill all the predefined success criteria in the protocol.	up to 12 months post-implantation
Primary	Peri-implantitis rate	Peri-implantitis is an inflammatory process affecting the tissues around the implant and causing loss of bone support (diagnosed by radiographic and clinical assessment).	12 months post-implantation
Primary	Mean osseointegration period	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).	From the implantation up to 12 months