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

Completed

• Conditions: Edentulous Alveolar Ridge; Implant-supported Fixed Prosthesis; Dental Implant; Dental Restoration

• Registration Number: NCT03582657
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-15
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-11
• Study Start: 2019-02-04
• Primary Completion: 2020-09-05
• Study Completion: 2022-01-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-01
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).
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.

Trial Locations

Locations (1)

Dr KHOURY Elias; 🇫🇷 Paris, France