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

Recruiting

• Conditions: Dental Implant; Implant-supported Fixed Prosthesis; Dentistry; Dental Restoration
• Interventions: Device: KONTACT MB

• Registration Number: NCT05016258
• Lead Sponsor: Biotech Dental

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-16
• Study First Posted: 2021-08-23
• Study Start: 2022-01-26
• Status Verified: 2022-03
• Primary Completion: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
KONTACT MB	KONTACT MB	Adult patients needed one or multiple implant-supported fixed restoration(s)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hadi Antoun Office; 🇫🇷 Paris, France