Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant

NCT05016401 | Completed

• 1 other identifier: 2020-A01491-38
• Study Type: observational
• Target: 199
• Locations: 1 country
• Sites: 1

Brief Summary

As part of post-marketing clinical follow-up, BIOTECH DENTAL sets up the collection and evaluation of clinical data proactively with the aim of confirming the safety, performance as well as the constantly acceptable nature of the risks identified and of detecting potential emerging risks with the use of "Kontact Perio Level" implants in everyday practice.

Conditions

Tooth Loss; Partially Edentulous Maxilla; Partially Edentulous Mandible

Outcome Measures

Primary Outcomes (1)

• Success rate

  For an implant to be declared "successful" it must meet the following criteria as defined by Albrektsson et al. 1986 adapted: Lack of mobility ; Absence of pain ; Lack of radiolucency around the implant ; Absence of bleeding and inflammation ; No significant peri-implant periodontal pocket (≤4mm) ; Stability of the peri-implant bone level over time with marginal bone loss ≤1.5 mm the first year and ≤0.2 mm the following years

  12 months

Secondary Outcomes (7)

• Bone Level

  12 months

• Prosthetic complications

  12 months

• Primary stability

  surgical time

• Survival rate

  12 months

• Factors that influence the survival and success rate

  12 months

Interventions

KONTACT PERIO LEVEL (KPL) DEVICE

The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.

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 eligible and planned for an implant-supported prosthetic restoration according to the instructions for use of the KONTACT PERIO LEVEL dental implant.

You may qualify if:

• Edentulous patient requiring the placement of one (or more) dental implant (s) in the maxilla or mandibular
• Age ≥ 18 years old
• Good general health (ASA score between \[1-2\])
• Sufficient volume and bone quality (with or without bone graft) to support the implant
• Non-objection of the patient for the collection of his medical data as part of the study

You may not qualify if:

• Poor oral hygiene
• Bruxism, parafunctional habits, occlusion disorders and / or temporomandibular joints
• Infections and oral inflammation such as active periodontitis, active 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)

Coordinating Investigator

Bandol, 83150, France

Location

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Design

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

Study Record Dates

• First Submitted: August 17, 2021
• First Posted: August 23, 2021
• Study Start: November 6, 2020
• Primary Completion: November 30, 2022
• Study Completion: February 2, 2023
• Last Updated: February 8, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)