DentistryNCT05016258
Performance and Safety Use of the Mono Block Implant "KONTACT MB"
An observational study of Dentistry and Dental Implant, run by Biotech Dental at 1 site in France.
Trial summary
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dentistry, Dental Implant, Dental Restoration
- What is being tested?
- KONTACT MB
- Type of treatment
- Medical device
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2022to Oct 2025
- 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 MB 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
- Given a writing consent 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.
Pascal Breysse contact
France1 site, 1 recruiting
- Recruiting
Hadi Antoun Office
Paris, 75017
Hadi Antoun, hadi@antoun.fr
About this study
Official title: Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.
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.
- Being tested
- KONTACT MB
- Keywords
- Mono Block design, KONTACT MB, Biotech Dental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KONTACT MBDevice
Also called Biotech Dental
Dental implant surgery
| Study group | Role | What they receive |
|---|---|---|
| KONTACT MB | Adult patients needed one or multiple implant-supported fixed restoration(s) Receives: Device: KONTACT MB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate
Number of implants still in function up to 36 months post implantation
Measured: up to 36 months
Peri implant bone level
Bone level evolution compare to the bone level at implantation day
Measured: up to 36 months
Keratinized tissues level
Assessment of keratinized tissues
Measured: up to 36 months
Gingival index
Gingival index assess with Loë and Silness Score
Measured: up to 36 months
Bleeding index
Bleeding index on probing following the Mombelli score
Measured: up to 36 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 start26 Jan 2022
- Primary completionFeb 2023 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DentistryStudies 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
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biotech Dental
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hadi Antoun, Principal investigator, Hadi Antoun office
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016258
- Sponsor's protocol ID
- 2021-A01757-34
- Status last verified
- Mar 2022
- First submitted
- 16 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 on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice
- ClinicalTrials.gov ID
- NCT05016258
- Acronym / sponsor ID
- 2021-A01757-34
- Keywords
- Mono Block design, KONTACT MB, Biotech Dental
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Biotech DentalIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Oct 2025 (estimated)
- 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.
A multicenter prospective observational study aims to illustrate the clinical outcome of dental implants "Kontact MB" and the effects of its Mono Block design on the peri implant bone tissue recession and soft tissue conservation.
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
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KONTACT MB | – | Device: KONTACT MBAdult patients needed one or multiple implant-supported fixed restoration(s) |
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 MB 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
- Given a writing consent 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 |
|---|---|---|
| KONTACT MBAlso: Biotech DentalDental implant surgery | Device | KONTACT MB |
Primary outcome
Implant survival rate
Time frame: up to 36 months
Number of implants still in function up to 36 months post implantation
Peri implant bone level
Time frame: up to 36 months
Bone level evolution compare to the bone level at implantation day
Keratinized tissues level
Time frame: up to 36 months
Assessment of keratinized tissues
Gingival index
Time frame: up to 36 months
Gingival index assess with Loë and Silness Score
Bleeding index
Time frame: up to 36 months
Bleeding index on probing following the Mombelli score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Dentistry
Active, not recruiting
HRVB for Stress and Anxiety During Dentistry Students' Clinical Transition
Stress (Psychology), Anxiety
Recruiting
Comparison of Digital Intraosseous and Manual Intraligamentary Anesthesia in Children
Anesthesia, Local
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Recruiting
Comparative Evaluation of Intranasal Atomized Midazalom Combined With Nitrous Oxide Versus Nitrous Oxide Monotherapy
Dental Anxiety in Children, Child Behaviour
Not yet recruiting
Clinical Performance of Glass Hybrid and Alkasite Restorative Systems in MIH-Affected Permanent First Molars
Molar-Incisor Hypomineralization (MIH)
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.
Pascal Breysse contact
Hadi Antoun principal investigator
Hadi Antoun office
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 Dentistry and Dental Implant, 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile Reynès ((0)626110768 ext. +33, c.reynes@biotech-dental.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival rate (time frame: up to 36 months). The study lists 5 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 8 Feb 2023.