Evaluating the KONTACT MB dental implant's performance and safety
Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice
This study is testing how well the KONTACT MB dental implants work and if they are safe for people getting one or more dental implants.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 159 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Biotech Dental Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Paris) |
| Trial ID | NCT05016258 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective observational study aims to assess the clinical outcomes of the KONTACT MB dental implants, focusing on the impact of its Mono Block design on peri-implant bone tissue recession and soft tissue conservation. Patients requiring one or more implant-supported fixed restorations will be enrolled according to routine clinical practices and the manufacturer's guidelines. The study will collect data on the implants' performance and safety over time, providing valuable insights into their effectiveness in dental restoration.
Who should consider this trial
Good fit: Ideal candidates include edentulous patients aged 18 and older with sufficient bone volume and quality for dental implants.
Not a fit: Patients with poor oral hygiene, bruxism, or significant medical conditions that may affect healing are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of dental implant performance, leading to improved outcomes for patients receiving dental restorations.
How similar studies have performed: While there may be existing studies on dental implants, the specific focus on the KONTACT MB's Mono Block design represents a novel approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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 * Given a writing consent for the collection of his medical data as part of the study (delivery of a patient's sheet) Exclusion Criteria: * 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 * 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
Where this trial is running
Paris
- Hadi Antoun Office — Paris, France (Recruiting)
Study contacts
- Principal investigator: Hadi Antoun — Hadi Antoun office
- Study coordinator: Cécile Reynès
- Email: c.reynes@biotech-dental.com
- Phone: (0)626110768
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.