Edentulism240101NCT06287346
5-Years PMCF Study of Ceramic Dental Implants One-piece Versus Two-piece.
An observational study of Edentulism and Tooth Loss, run by CeraRoot SL at 2 sites in 2 countries.
Trial summary
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question[s] it aims to answer are: Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulism, Tooth Loss
- What is being tested?
- dental implant
- Type of treatment
- Medical device
- How many people
- 652 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jan 2024to 1 Jan 2030
- How long will I take part?
- 1 Year
- 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: The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).
Who may be able to join
- Clinical Diagnosis of partial or total edentulism.
- Specially indicated for patients with metal allergies and chronic illness due to metal allergies.
Who cannot join
- General Contraindications:
- Local and Systemic contraindications for surgery.
- Poor oral hygiene
- Patients with health problems, disease or any physical or psychological condition to which an oral surgery may be contraindicated.
- Relative Contraindications:
- Previously irradiated bone
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- diabetes
- anticoagulant medication
- hemodynamic problems
- bruxism
- Para functional habits
- bad bone anatomy
- smokers
- none controlled periodontitis
- malocclusions
- TMJ problems
- diseases in the oral cavity
- pregnancy
- insufficient oral hygiene for adequate health.
- Local contraindications
- insufficient bone quantity or quality
- remaining of roots
- localized periodontal disease
- Any pathology in the neighboring teeth.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Family Holistic Dentistry
Boulder, Colorado, 80303
CARMEN BURKE, DDS, 303-219-0499, carmen@carmenburke.com
CARMEN BURKE, DDS
Spain1 site, 1 recruiting
- Recruiting
CeraRoot CLINIC
Les Franqueses del Vallès, Barcelona, 08520
JOSEP OLIVA-OCHOA, DDS MSC, 800-485-1613, josep.oliva@cerarootclinic.com
Ekaterina Treatment coordinator, +34 935 950 247, ekaterina@ceraroot.com
About this study
Official title: 5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question[s] it aims to answer are:
- Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
- What are the complications associated to the procedure and differences between the two groups.
Read the detailed description
The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).
The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
- Conditions
- Edentulism, Tooth Loss
- Being tested
- dental implant
- Keywords
- dental implant, ceramic dental implant, zirconia implant, y-tzp, metal-free
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental implantDevice
ceramic dental implant
| Study group | Role | What they receive |
|---|---|---|
| One-piece | One-piece CeraRoot dental implants Receives: Device: dental implant | |
| Two-piece (TL) | Two-piece CeraRoot TL dental implants Receives: Device: dental implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.
Measured: From enrolment to the end of treatment 12 months or more.
Secondary outcomes (1)
Complications
Implantitis, mucositis, pain, implant fracture, prosthetic fracture, bone loss,
Measured: 1 year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EdentulismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 652 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- CeraRoot SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287346
- Sponsor's protocol ID
- 240101
- Acronym
- 240101
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: at the end of the study the results will be published including, method and results survival rates and complications rate. For this reason no need to share any other information
Publications
undefined
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 5-Years Multicentric Prospective Post-Market Clinical Follow-up (PMCF) Comparative Study of CeraRoot Ceramic Dental Implants One-piece Versus Two-piece.
- ClinicalTrials.gov ID
- NCT06287346
- Acronym / sponsor ID
- 240101 / 240101
- Conditions
- Edentulism, Tooth Loss
- Keywords
- dental implant, ceramic dental implant, zirconia implant, y-tzp, metal-free
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 652 participants (estimated)
- Lead sponsor
- CeraRoot SLIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 1 Mar 2024 (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.
The goal of this cohort observational study is to compare in the survival rate of ceramic dental implants placed in patients with missing or hopeless teeth . The main question[s] it aims to answer are:
- Are there any significant differences in survival rate between the use of one-piece ceramic implant versus the two-piece (TL) variant?
- What are the complications associated to the procedure and differences between the two groups.
Detailed description
The present clinical study protocol has the objective to compare the performance of different CeraRoot ceramic implant models (16,11,21,12,14,34,34L) and the different sub-variants (one-piece versus two-piece).
The geographic population of study will be the patients in two different dental centers located in Barcelona (Spain) and Boulder (Colorado, USA). The intended population as described in the device instruction for use (3) is " Intended Population: All fully-grown patients (men or women) requiring dental reconstruction using dental implants and who have no contraindications. The CeraRoot® dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-piece | – | Device: dental implantOne-piece CeraRoot dental implants |
| Two-piece (TL) | – | Device: dental implantTwo-piece CeraRoot TL dental implants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The geographic population of study will be the patients in two different private dental centers located in Barcelona (Spain) and Boulder (Colorado, USA).
Key inclusion criteria (2 listed)
- Clinical Diagnosis of partial or total edentulism.
- Specially indicated for patients with metal allergies and chronic illness due to metal allergies.
Key exclusion criteria (24 listed)
- General Contraindications:
- Relative Contraindications:
- Local contraindications
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 implantceramic dental implant | Device | One-piece, Two-piece (TL) |
Primary outcome
Survival rate
Time frame: From enrolment to the end of treatment 12 months or more.
The implant is osseointegrated and in function in the patient's jaw without pain and no mobility.
1 secondary outcome
Complications
Time frame: 1 year after treatment
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 1 Mar 2024.
- Backgroundundefined
- Individual participant dataSharing planned: No. at the end of the study the results will be published including, method and results survival rates and complications rate. For this reason no need to share any other information
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulism and Tooth Loss, run by CeraRoot SL at 2 sites in 2 countries.
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 2 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Spain. 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?
Contact JOSEP Oliva, Dentist, DDS MSC (800-485-1613, josep.oliva@cerarootclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: From enrolment to the end of treatment 12 months or more.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287346, which also lists 1 linked publication.
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 1 Mar 2024.