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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Edentulous Mouth
• Intervention / Treatment: Device: Dental implant

Detailed Description

Many adults have one or more missing teeth. The negative consequences of partial or total edentulousness are numerous in the orofacial sphere:

• Edentulousness causes a strong aesthetic deficit due to the lack of support of facial tissues and musculature;
• Edentulousness generates a functional deficit that can have significant repercussions on the nutritional status of the affected subject;
• Edentulousness is accompanied by bone resorption of the jawbones which is inevitable in the absence of implant treatment;
• In addition, the resulting feelings of discomfort and fragility are experienced as a real psychological handicap by the patient, partially or totally edentulous, which can then have significant repercussions on his social life.

TBR® Tissue Level Z1 implants are intended for placement in the maxillary or mandibular arch in partially or completely edentulous patients for prosthetic restoration in the following cases:

• Single edentulousness,
• Intercalary edentulousness,
• Terminal edentulousness,
• Total edentulousness.

The following clinical conditions must be observed before placing a dental implant:

• Sufficient quality and volume of bone support;
• Healthy oral condition;
• no contraindications for implant setting

The procedure used to accomplish its intended use is as follows:

• The receiving implant site is prepared using an established drilling sequence then the implant is placed in this site: the body of the implant (in titanium) has an endosseous position while the ring (in ceramic) remains transgingival;
• After an osseointegration time, the final prosthetic abutment will be loaded on the implant.

The expected benefits of this surgery are to improve the quality of life of patients, to recover the chewing function and the aesthetics of the smile.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

• Study Contact: Name: Camille PIERRE; Phone Number: +033 05 62 16 71 00; Email: cpierre@tbr.dental
• Study Contact Backup: Name: Nhu-Tuyet HA MINH; Phone Number: +033 05 62 16 71 00; Email: haminh@tbr.dental

Study Locations

• France
  • Montpellier, France, 34000
    • Cabinet du Dr ALLOUCHE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient partially or totally toothless

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the success rate of tissue integration of the implant	Integration of the implant 15 years after implantation	15 years after implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of the quality of life of patients following the recovery of a complete dentition with the OHIP- 14 score (Oral Health Impact Profile)	The quality of life of patients will be evaluate with the OHIP- 14 score (Oral Health Impact Profile) before implantation and 5 years after implantation	5 years after implantation
Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture	pain, local tenderness, infection, allergy, mobility of the implant, fracture will be collected during during the 5 years follow-up	5 years after implantation
Measuring chewing function with occlusal assessment	Occlusal assessment will be performed after implantation and at 5 years follow-up	5 years after implantation
Radiographic analysis of the osseointegration of the implant	A radiographic analysiswill be performed after implantation and at 5 years follow-up to evaluate the osseointegration of the implant	5 years after implantation
Absence of inflammation (visual) and infection (radiographic)	Assessment of inflammation with visual examination and assessment of infection with radiographic examination 5 years after implantation	5 years after implantation

Collaborators and Investigators

• Sponsor: Sudimplant SAS - Groupe TBR

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: 2019-A01926-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No