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The main objective is to evaluate the success / failure rate of CeraRoot ceramic implants (one piece) during three year follow up.
Traditionally the material of choice for dental implants has been titanium. The success of such material has been unquestionable for the last decades. However a number of issues arise lately regarding the biocompatibility or cytotoxicity or allergies regarding the degradation or oxidation particles within the bone or gum. Esthetics has been a concern as well specially in patients with thin biotype where the metal may produce a grayish look of the mucosa. For this reason the dental community and patients have raised much interest in ceramic dental implants as a tooth colored and metal free alternative for dental implants.
Since 2006 CeraRoot ceramic implants have been available in the market.
The reason for designing this PMCF is to evaluate the long term success of CeraRoot ceramic implants
To achieve those objectives an observational study of patients that have received such implant is designed, using marginal bone loss as a primary response variable. It is estimated that a sample size 200 patients over the 3 year period is needed to achieve relevant data.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Implants That Survived | Implant without pain, without mobility and in function. | Baseline to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Implants With Surgical Complications (SC) | Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected | Baseline to 7 days |
| Number of Implants With Before Loading Implants Complications (BLIC) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients that needed a tooth replacement that fulfilled the eligibility criteria.
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| Name | Affiliation | Role |
|---|---|---|
| JOSEP OLIVA-OCHOA, MSC | CeraRoot SL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CeraRoot CLINIC | Les Franqueses del Vallès | Barcelona | 08520 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21806681 | Background | Gahlert M, Roehling S, Sprecher CM, Kniha H, Milz S, Bormann K. In vivo performance of zirconia and titanium implants: a histomorphometric study in mini pig maxillae. Clin Oral Implants Res. 2012 Mar;23(3):281-6. doi: 10.1111/j.1600-0501.2011.02157.x. Epub 2011 Aug 2. | |
| 22519944 | Background | Kohal RJ, Knauf M, Larsson B, Sahlin H, Butz F. One-piece zirconia oral implants: one-year results from a prospective cohort study. 1. Single tooth replacement. J Clin Periodontol. 2012 Jun;39(6):590-7. doi: 10.1111/j.1600-051X.2012.01876.x. Epub 2012 Apr 23. |
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98 patients with a total of 175 implants met the inclusion criteria.
Participants were included if received a CeraRoot implant between August 27th 2020 and December 4th 2023, provided the inclusion criteria were met.
| ID | Title | Description |
|---|---|---|
| FG000 | CeraRoot Ceramic Implants | patients that received CeraRoot ceramic implants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants received CeraRoot ceramic implant one-piece.
| ID | Title | Description |
|---|---|---|
| BG000 | CeraRoot Implant | CeraRoot ceramic dental implant one-piece |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Implants That Survived | Implant without pain, without mobility and in function. | Posted | Count of Units | implants | Baseline to 3 years | implants | implants |
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3 years
FDA protocols for adverse event reporting are considered in this clinical trial in case of need for notification.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CeraRoot Implants | CeraRoot ceramic implants one-piece | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Josep Oliva-Ochoa. Director of Clinical Trials | CeraRoot CLINIC | +34 935950247 | josep.oliva@cerarootclinic.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 21, 2024 | Oct 18, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected |
| 7 days post operative to delivery of prosthesis |
| Number of Implants With After Loading Implants Complications (ALIC) | Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded. | From delivery of prosthesis to two years later. |
| Number of Units With Prosthetic Complications (PC) | Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered. | Baseline to 3 years |
| 22335358 | Background | Payer M, Arnetzl V, Kirmeier R, Koller M, Arnetzl G, Jakse N. Immediate provisional restoration of single-piece zirconia implants: a prospective case series - results after 24 months of clinical function. Clin Oral Implants Res. 2013 May;24(5):569-75. doi: 10.1111/j.1600-0501.2012.02425.x. Epub 2012 Feb 15. |
| 23748325 | Background | Gahlert M, Burtscher D, Pfundstein G, Grunert I, Kniha H, Roehling S. Dental zirconia implants up to three years in function: a retrospective clinical study and evaluation of prosthetic restorations and failures. Int J Oral Maxillofac Implants. 2013 May-Jun;28(3):896-904. doi: 10.11607/jomi.2211. |
| 24112624 | Background | Siddiqi A, Kieser JA, De Silva RK, Thomson WM, Duncan WJ. Soft and Hard Tissue Response to Zirconia versus Titanium One-Piece Implants Placed in Alveolar and Palatal Sites: A Randomized Control Trial. Clin Implant Dent Relat Res. 2015 Jun;17(3):483-96. doi: 10.1111/cid.12159. Epub 2013 Sep 23. |
| 27217032 | Background | Hashim D, Cionca N, Courvoisier DS, Mombelli A. A systematic review of the clinical survival of zirconia implants. Clin Oral Investig. 2016 Sep;20(7):1403-17. doi: 10.1007/s00784-016-1853-9. Epub 2016 May 24. |
| 20369093 | Background | Oliva J, Oliva X, Oliva JD. Five-year success rate of 831 consecutively placed Zirconia dental implants in humans: a comparison of three different rough surfaces. Int J Oral Maxillofac Implants. 2010 Mar-Apr;25(2):336-44. |
| 37083912 | Background | Oliva J, Oliva X. 15-Year Post-Market Clinical Follow-up Study of 1,828 Ceramic (Zirconia) Implants in Humans. Int J Oral Maxillofac Implants. 2023 Mar-Apr;38(2):357-366. doi: 10.11607/jomi.10000. |
| implants |
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| Participants |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants | Participants |
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| implants |
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| Secondary | Number of Implants With Surgical Complications (SC) | Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will be collected | Posted | Count of Units | implants | Baseline to 7 days | implants | implants |
|
|
|
| Secondary | Number of Implants With Before Loading Implants Complications (BLIC) | Any complications before the prosthesis is delivered (implant mobility, implant infection, implant loss...) will be collected | Posted | Count of Units | implants | 7 days post operative to delivery of prosthesis | implants | implants |
|
|
|
| Secondary | Number of Implants With After Loading Implants Complications (ALIC) | Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...) that may appear will be recorded. | Patients that received CeraRoot implants and were not excluded from the study. | Posted | Count of Units | implants | From delivery of prosthesis to two years later. | implants | implants |
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| Secondary | Number of Units With Prosthetic Complications (PC) | Any difficulty during the confection of the crown, complications as decementation, chipping, etc... will be registered. | Posted | Count of Units | implants | Baseline to 3 years | implants | implants |
|
|
|
| 98 |
| 0 |
| 98 |
| 0 |
| 98 |
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| Title | Measurements |
|---|---|
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| Sinus Infection |
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