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

Active, not recruiting

• Conditions: Edentulous

• Registration Number: NCT04984486
• Lead Sponsor: Sudimplant SAS - Groupe TBR

Brief Summary

Partial or total edentulousness has a significant impact on quality of life both functionally and aesthetically.

TBR® Bone Level 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.

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® Bone Level 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 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 Timeline

• Study First Submitted: 2021-07-21
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Study Start: 2021-09-27
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-25
• Last Update Posted: 2024-04-26
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 138

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® Bone Level 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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the success rate of tissue integration of the implant	15 years after implantation	Integration of the implant 15 years after implantation

Secondary Outcome Measures

Name	Time	Method
Absence of inflammation (visual) and infection (radiographic)	5 years after implantation	Assessment of inflammation with visual examination and assessment of infection with radiographic examination 5 years after implantation
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	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
Measuring chewing function with occlusal assessment	5 years after implantation	Occlusal assessment will be performed after implantation and at 5 years follow-up
Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture	5 years after implantation	pain, local tenderness, infection, allergy, mobility of the implant, fracture will be collected during during the 5 years follow-up
Radiographic analysis of the osseointegration of the implant	5 years after implantation	A radiographic analysiswill be performed after implantation and at 5 years follow-up to evaluate the osseointegration of the implant

Trial Locations

Locations (1)

Cabinet du Dr ALLOUCHE; 🇫🇷 Montpellier, France