In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1

NCT04984499 | Active Not Recruiting

• 1 other identifier: 2019-A01926-51
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically. TBR® Tissue Level Z1 Implants allow the patient to prevent bone resorption and maintain facial tissue and musculature support. At the functional level, the patient who benefits from implant treatment regains normal masticatory function with all the benefits on the quality of life that this can bring him. Due to the osseointegration of the implant and the biocompatibility of the materials used, the implant treatment remains effective in the long term and makes it possible to maintain the aesthetics of the smile.

Conditions

Edentulous Mouth

Outcome Measures

Primary Outcomes (1)

• the success rate of tissue integration of the implant

  Integration of the implant 15 years after implantation

  15 years after implantation

Secondary Outcomes (5)

• Change of the quality of life of patients following the recovery of a complete dentition with the OHIP- 14 score (Oral Health Impact Profile)

  5 years after implantation

• Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture

  5 years after implantation

• Measuring chewing function with occlusal assessment

  5 years after implantation

• Radiographic analysis of the osseointegration of the implant

  5 years after implantation

• Absence of inflammation (visual) and infection (radiographic)

  5 years after implantation

Interventions

Dental implant DEVICE

The procedure used to accomplish its intended use is as follows : The recipient implant site is prepared using a drilling sequence, then the implant is placed at the crestal level with a cover screw to allow the tissues healing. After this healing phase, the final prosthesis will be loaded on the implant.

Eligibility Criteria

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

Study Population

Patient partially or totally toothless

You may qualify if:

• Patient 18 years of age or older
• Patient who has completed bone growth
• Patient informed and willing to participate in the study
• Partially or totally toothless patient who will be implanted with the TBR® Bone Level implant(s) for the prospective cohort
• Patient implanted with the TBR® TISSUE LEVEL Z1 implant(s) before June 2011 for the retrospective cohort

You may not qualify if:

• Pregnant or lactating women
• Patient with bone disease of the head and neck region
• Patient refusing to participate in the study
• Patient with at least one contraindication to implantation
• Patient on osteoporosis treatment with Biphosphonates or Denosumab.

Sponsors & Collaborators

• Sudimplant SAS - Groupe TBR: lead

Study Sites (1)

Cabinet du Dr ALLOUCHE

Montpellier, 34000, France

Location

MeSH Terms

Conditions

Mouth, Edentulous

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: September 23, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 26, 2024

Record last verified: 2024-04

Locations

FR (1)