Tooth LossKPLNCT05016401
Performance and Safety of Use of the "KONTACT PERIO LEVEL" Transgingival Titanium Dental Implant
An observational study of Tooth Loss and Partially Edentulous Maxilla, run by Biotech Dental at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tooth Loss, Partially Edentulous Maxilla, Partially Edentulous Mandible
- What is being tested?
- KONTACT PERIO LEVEL (KPL)
- Type of treatment
- Medical device
- How many people
- 199 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2020to 2 Feb 2023
- 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 eligible and planned for an implant-supported prosthetic restoration according to the instructions for use of the KONTACT PERIO LEVEL dental implant.
Who may be able to join
- 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
Who cannot join
- 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
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 Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.
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.
- Being tested
- KONTACT PERIO LEVEL (KPL)
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KONTACT PERIO LEVEL (KPL)Device
The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (7)
Bone Level
Peri-implant marginal bone loss and / or regrowth is calculated using x-rays
Measured: 12 months
Prosthetic complications
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.)
Measured: 12 months
Primary stability
Value of the torque during implant placement
Measured: surgical time
Survival rate
An implant is classified as "surviving" if it is still in operation at some point t
Measured: 12 months
Factors that influence the survival and success rate
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;...
Measured: 12 months
Peri-implantitis
Number of peri-implantitis (inflammatory disease causing bone loss around an implant)
Measured: 12 months
Quality of Life
Evolution of the quality of life score calculated using GOHAI (General Oral Health Assessment Index)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start6 Nov 2020
- Primary completion30 Nov 2022
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotech Dental
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016401
- Sponsor's protocol ID
- 2020-A01491-38
- Acronym
- KPL
- Status last verified
- Aug 2021
- First submitted
- 17 Aug 2021
- Last updated
- 8 Feb 2023
- 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 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study Evaluating the Performance and Safety of Use of the "KONTACT PERIO LEVEL" Dental Implant in Routine Clinical Practice.
- ClinicalTrials.gov ID
- NCT05016401
- Acronym / sponsor ID
- KPL / 2020-A01491-38
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Biotech DentalIndustry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 23 Aug 2021 (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.
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.
Study design
- Observational model
- Case only
- 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 eligible and planned for an implant-supported prosthetic restoration according to the instructions for use of the KONTACT PERIO LEVEL dental implant.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
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 |
|---|---|---|
| KONTACT PERIO LEVEL (KPL)The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery. | Device | – |
Primary outcome
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
7 secondary outcomes
Bone Level
Time frame: 12 months
Prosthetic complications
Time frame: 12 months
Primary stability
Time frame: surgical time
Survival rate
Time frame: 12 months
Factors that influence the survival and success rate
Time frame: 12 months
Peri-implantitis
Time frame: 12 months
Quality of Life
Time frame: 12 months
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 8 Feb 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tooth Loss and Partially Edentulous Maxilla, 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 8 Feb 2023. 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?
Success rate (time frame: 12 months). 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 8 Feb 2023.