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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582657
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Dental Implant Dental Restoration Edentulous Alveolar Ridge Implant-supported Fixed Prosthesis Device: dental implant (KONTACT N)

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Study Type : Observational
Estimated Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

Intervention Details:
  • Device: dental implant (KONTACT N)
    Implant-supported prosthetic restoration
    Other Names:
    • KONTACT N
    • BIOTECH DENTAL


Primary Outcome Measures :
  1. Implant success rate [ Time Frame: 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.

  2. Peri-implantitis rate [ Time Frame: 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).

  3. Mean osseointegration period [ Time Frame: 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582657


Contacts
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Contact: Alexandra SANS (0)626110768 ext +33 a.sans@biotech-dental.com
Contact: Pascal BREYSSE p.breysse@biotech-dental.com

Locations
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France
Dr KHOURY Elias Recruiting
Paris, France
Sponsors and Collaborators
Biotech Dental
Investigators
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Principal Investigator: KHOURY, Dr
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Responsible Party: Biotech Dental
ClinicalTrials.gov Identifier: NCT03582657    
Other Study ID Numbers: 2018-A00194-51
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Biotech Dental:
nanostructured-implant
titanium implant
nano-roughness surface
hydrophilic surface
KONTACT N
BIOTECH DENTAL
Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases