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OpenTrials
Completed

NCT Number: NCT05016401

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

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.

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Key information

Conditions

Tooth Loss Mouth Diseases Partially Edentulous Mandible Partially Edentulous Maxilla Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coordinating Investigator

Bandol, 83150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

KONTACT PERIO LEVEL (KPL)

Device

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

Primary outcomes

  1. Success rate

    Time frame: 12 months

    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

Secondary outcomes

  1. Bone Level

    Time frame: 12 months

    Peri-implant marginal bone loss and / or regrowth is calculated using x-rays

  2. Prosthetic complications

    Time frame: 12 months

    All prosthetic complications having affected the restorations on implants, from the placement of the provisional restorations until the end of the study, are recorded (loosening of the abutment screws, the fracture of the abutment, loss of retention, fracture, etc.)

  3. Primary stability

    Time frame: surgical time

    Value of the torque during implant placement

  4. Survival rate

    Time frame: 12 months

    An implant is classified as "surviving" if it is still in operation at some point t

  5. Factors that influence the survival and success rate

    Time frame: 12 months

    Univariate statistical analysis of the success and survival rate as a function of: age; sex; bone density; site of implantation; bone graft; type of prosthesis; jaw type;...

  6. Peri-implantitis

    Time frame: 12 months

    Number of peri-implantitis (inflammatory disease causing bone loss around an implant)

  7. Quality of Life

    Time frame: 12 months

    Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index)

Sponsors and collaborators

Lead sponsor

Biotech Dental

Industry

Registry information

Official study title

Multicenter Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.

Acronym: KPL

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Aug 23, 2021
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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