Dental ImplantNCT03582657
Performance and Safety Use of the Nanostructured Titanium Dental Implant "KONTACT N"
An observational study of Dental Implant and Dental Restoration, run by Biotech Dental at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Dental Restoration, Edentulous Alveolar Ridge
- What is being tested?
- dental implant (KONTACT N)
- Type of treatment
- Medical device
- How many people
- 164 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2019to 13 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice
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
- Being tested
- dental implant (KONTACT N)
- Keywords
- nanostructured-implant, titanium implant, nano-roughness surface, hydrophilic surface, KONTACT N, BIOTECH DENTAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implant (KONTACT N)Device
Also called KONTACT N, BIOTECH DENTAL
Implant-supported prosthetic restoration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: From the implantation up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start4 Feb 2019
- Primary completion5 Sep 2020
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Dental
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- KHOURY, Dr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582657
- Sponsor's protocol ID
- 2018-A00194-51
- Status last verified
- Mar 2022
- First submitted
- 15 Jun 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Observational Study on the Performance and Safety Use of the Dental Implant "KONTACT N" in the Current Clinical Practice
- ClinicalTrials.gov ID
- NCT03582657
- Acronym / sponsor ID
- 2018-A00194-51
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Biotech DentalIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dental implant (KONTACT N)Also: KONTACT N, BIOTECH DENTALImplant-supported prosthetic restoration | Device | – |
Primary outcome
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.
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KHOURY, Dr principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implant and Dental Restoration, run by Biotech Dental at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant success rate (time frame: up to 12 months post-implantation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.