- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04984486
In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Bone Level
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.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Camille PIERRE
- Phone Number: +33 (0) 5 62 16 71 00
- Email: cpierre@tbr.dental
Study Contact Backup
- Name: Nhu-Tuyet HA MINH
- Phone Number: +33 (0) 5 62 16 71 00
- Email: haminh@tbr.dental
Study Locations
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Montpellier, France, 34000
- Cabinet du Dr ALLOUCHE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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® 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 Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the success rate of tissue integration of the implant
Time Frame: 15 years after implantation
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Integration of the implant 15 years after implantation
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15 years after implantation
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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)
Time Frame: 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
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5 years after implantation
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Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture
Time Frame: 5 years after implantation
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pain, local tenderness, infection, allergy, mobility of the implant, fracture will be collected during during the 5 years follow-up
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5 years after implantation
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Measuring chewing function with occlusal assessment
Time Frame: 5 years after implantation
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Occlusal assessment will be performed after implantation and at 5 years follow-up
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5 years after implantation
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Radiographic analysis of the osseointegration of the implant
Time Frame: 5 years after implantation
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A radiographic analysiswill be performed after implantation and at 5 years follow-up to evaluate the osseointegration of the implant
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5 years after implantation
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Absence of inflammation (visual) and infection (radiographic)
Time Frame: 5 years after implantation
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Assessment of inflammation with visual examination and assessment of infection with radiographic examination 5 years after implantation
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5 years after implantation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laurent ALLOUCHE, Dr, Cabinet Dentaire du Dr Laurent ALLOUCHE
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-A01913-54
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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