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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Implant; Edentulous Alveolar Ridge; Dental Restoration; Implant-supported Fixed Prosthesis
• Intervention / Treatment: Device: dental implant (KONTACT N)

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Dr KHOURY Elias

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Biotech Dental
• Investigators: Principal Investigator: KHOURY, Dr

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2019
• Primary Completion (ACTUAL): September 5, 2020
• Study Completion (ACTUAL): January 13, 2022

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: nanostructured-implant; titanium implant; nano-roughness surface; hydrophilic surface; KONTACT N; BIOTECH DENTAL
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 2018-A00194-51

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No