In Vivo Clinical Investigation of the Safety & Performance of Dental

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04984499
Study type	Observational
Source	Sudimplant SAS - Groupe TBR
Contact
Status	Active, not recruiting
Phase
Start date	September 23, 2021
Completion date	July 2027

View Details

See also
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Active, not recruiting	`NCT05599269` - Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth	N/A
Not yet recruiting	`NCT03674554` - Prosthetic Complications of Screw Retained Restoration	N/A
Not yet recruiting	`NCT06155630` - 3D Printing for the Fabrication of Mandibular Implant Overdentures	N/A
Active, not recruiting	`NCT02117856` - Complete Lower Dentures on 1 or 2 Implants	N/A
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Completed	`NCT04760457` - Mandibular Overdentures Retained by Mini Implants: a Clinical Trial Comparing Different Surgical and Loading Protocols	N/A
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Enrolling by invitation	`NCT05441527` - Use of Two Dissolvable Therapeutics Under Removable Partial Dentures	N/A
Completed	`NCT03056976` - Cost-effectiveness of Implant Treatment for the Edentulous Mandible	N/A
Completed	`NCT04475913` - Digital vs Analog Impression in Cases of All-on-4 - Prosthesis	N/A
Recruiting	`NCT03536468` - Psychological Impact of Tooth Loss
Completed	`NCT03048812` - Attachment Types for Single-implant Mandibular Overdentures: a Crossover Clinical Trial	N/A
Recruiting	`NCT02339194` - Application of a Simplified Method of Complete Denture Fabrication for Severely Resorbed Mandibular Ridges	Phase 3
Completed	`NCT04366895` - 3D -Printed Single Implant Overdentures	N/A
Completed	`NCT04569929` - 3D-printed Implant Overdentures	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms