Edentulous MouthZ1NCT04984499
In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1
An observational study of Edentulous Mouth, run by Sudimplant SAS - Groupe TBR at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Mouth
- What is being tested?
- Dental implant
- Type of treatment
- Medical device
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2021to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient partially or totally toothless
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Edentulous Mouth
- Being tested
- Dental implant
- Medical subject headings
- Mouth, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implantDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of tissue integration of the implant
Integration of the implant 15 years after implantation
Measured: 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)
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
Measured: 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
Measured: 5 years after implantation
Measuring chewing function with occlusal assessment
Occlusal assessment will be performed after implantation and at 5 years follow-up
Measured: 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
Measured: 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
Measured: 5 years after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start23 Sep 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous MouthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sudimplant SAS - Groupe TBR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984499
- Sponsor's protocol ID
- 2019-A01926-51
- Acronym
- Z1
- Status last verified
- Apr 2024
- First submitted
- 21 Jul 2021
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Clinical Investigation of the Safety and Performance of Dental Implants TBR® Tissue Level Z1 With Ceramic Emergence
- ClinicalTrials.gov ID
- NCT04984499
- Acronym / sponsor ID
- Z1 / 2019-A01926-51
- Conditions
- Edentulous Mouth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Sudimplant SAS - Groupe TBRIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient partially or totally toothless
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implantThe 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. | Device | – |
Primary outcome
the success rate of tissue integration of the implant
Time frame: 15 years after implantation
Integration of the implant 15 years after implantation
5 secondary outcomes
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
Complication rate taking into account pain, local tenderness, infection, allergy, mobility of the implant, fracture
Time frame: 5 years after implantation
Measuring chewing function with occlusal assessment
Time frame: 5 years after implantation
Radiographic analysis of the osseointegration of the implant
Time frame: 5 years after implantation
Absence of inflammation (visual) and infection (radiographic)
Time frame: 5 years after implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Mouth, run by Sudimplant SAS - Groupe TBR at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of tissue integration of the implant (time frame: 15 years after implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.