Performance and Safety Use of the Mono Block Implant "KONTACT MB"

Dental Implant Clinical Trial

Official title:

Multicenter Observational Study on Performance and Safety Use of "KONTACT MB" Dental Implant in Daily Practice

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016258
• Other study ID #: 2021-A01757-34
• Status: Recruiting
• Start date: January 26, 2022
• Est. completion date: October 2025

Study information

• Verified date: March 2022
• Source: Biotech Dental
• Contact: Cécile Reynès
• Phone: (0)626110768
• Email: c.reynes[@]biotech-dental.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 159
• Est. completion date: October 2025
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implant
• Dental Restoration
• Dentistry
• Implant-supported Fixed Prosthesis

Intervention

Device:
• KONTACT MB
Dental implant surgery

Locations

Country	Name	City	State
France	Hadi Antoun Office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Biotech Dental

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant survival rate	Number of implants still in function up to 36 months post implantation	up to 36 months
Primary	Peri implant bone level	Bone level evolution compare to the bone level at implantation day	up to 36 months
Primary	Keratinized tissues level	Assessment of keratinized tissues	up to 36 months
Primary	Gingival index	Gingival index assess with Loë and Silness Score	up to 36 months
Primary	Bleeding index	Bleeding index on probing following the Mombelli score	up to 36 months