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

NCT05016258 | Unknown

• 1 other identifier: 2021-A01757-34
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mono Block design; KONTACT MB; Biotech Dental

Outcome Measures

Primary Outcomes (5)

• Implant survival rate

  Number of implants still in function up to 36 months post implantation

  up to 36 months

• Peri implant bone level

  Bone level evolution compare to the bone level at implantation day

  up to 36 months

• Keratinized tissues level

  Assessment of keratinized tissues

  up to 36 months

• Gingival index

  Gingival index assess with Loë and Silness Score

  up to 36 months

• Bleeding index

  Bleeding index on probing following the Mombelli score

  up to 36 months

Study Arms (1)

KONTACT MB

Adult patients needed one or multiple implant-supported fixed restoration(s)

Device: KONTACT MB

Interventions

KONTACT MB DEVICE

Dental implant surgery

Also known as: Biotech Dental

KONTACT MB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotech Dental: lead

Study Sites (1)

Hadi Antoun Office

Paris, 75017, France

RECRUITING

Study Officials

• Hadi Antoun

  Hadi Antoun office

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Reynès

CONTACT

(0)626110768; c.reynes@biotech-dental.com

Pascal Breysse

CONTACT

p.breysse@biotech-dental.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 23, 2021
• Study Start: January 26, 2022
• Primary Completion: February 1, 2023
• Study Completion: October 1, 2025
• Last Updated: February 8, 2023

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)