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

NCT03582657 | Completed

• 1 other identifier: 2018-A00194-51
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

dental implant (KONTACT N) DEVICE

Implant-supported prosthetic restoration

Also known as: KONTACT N, BIOTECH DENTAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotech Dental: lead

Study Sites (1)

Dr KHOURY Elias

Paris, France

Location

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• KHOURY, Dr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: July 11, 2018
• Study Start: February 4, 2019
• Primary Completion: September 5, 2020
• Study Completion: January 13, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)