Post Market Clinical Follow up Study of CeraRoot Ceramic Implants One-piece: 3 Years Follow up
Conditions: Tooth Loss, Ceramic Implant
Sponsor: CeraRoot SL

Parpers, 13. 08520 Les Franqueses del Vallès
Barcelona. Catalonia. Spain
www.ceraroot.com info@ceraroot.com
Document Nº:
Protocol PMCF #200806
Page:
1 of 7
Created:
01/02/2020
Version:
21/07/2024
CLINICAL STUDY PROTOCOL
TITLE:
Post Market Clinical Follow up Study (PMCF) of CeraRoot
Ceramic Implants One-piece: 3 Years Follow up
(Period: 2020- 2023)
ID:200806
NCT: 04598776
Written and Approved:
Josep Oliva-Ochoa
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Protocol PMCF #200806
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1.Description of study
1.1. Brief Summary:
The main objective is to evaluate the survival / failure rate of CeraRoot ceramic implants (one
piece) during a three year follow up.
1.2. Detailed Description:
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, especially in patients with thin biotypes where the metal may produce a greyish
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.
2.Objectives
Since 2006 CeraRoot ceramic implants have been available in the market. The main goals 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 implants
is designed with implant survival as the main outcome measure.
3.Design
3.1. H0 (Null Hypothesis)
There are no significant differences between the failure rate in this study and the failures rates in
literature regarding this dental implant.
3.2. H1 (Alt.Hypothesis)
There are significant differences between the failure rate in this study and the failures rate in the
literature.
3.3. Study Type:
Observational [Patient Registry]
3.4. Observational Study Model:
Cohort
3.5. Time Perspective:
Prospective
3.6. Biospecimen Retention:
None Retained
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3.7. Biospecimen Description:
3.8. Enrollment:
200 [Anticipated/ predicted]
175 real participants enrolled in the study.
3.9. Number of Groups/Cohorts:
1
3.10. Target Follow-Up Duration:
3 Years
3.11. Groups and Interventions
no interventional
3.12. Outcome Measures
Primary Outcome Measure:
1. Implant Survival (Implant without pain, without mobility and in function.) [Time Frame:
Baseline until 3 years]
Secondary Outcome Measure:
2. Surgical complications (SC)
Any complications, as bleeding, infection, no primary stability, early loss.... that may appear will
be collected [Time Frame: Baseline to 7 days]
3. Before loading implants Complications (BLIC)
Any complications before the prosthesis is delivered (implant mobility, implant infection, implant
loss...) will be collected [Time Frame: 7 days post operative to delivery of prosthesis]
4. After loading implants Complications (ALIC)
Any complications after the prosthesis is delivered (implant loss, bone loss, implant mobility...)
that may appear will be recorded. [Time Frame: Baseline to 3 years]
5. Prosthetic Complications (PC)
Any difficulty during the confection of the crown, complications such as decementation, chipping,
etc... will be registered. [Time Frame: Baseline to 3 years]
6. Implant Success
Implant survival in addition to not having bone loss around it.( . [Time Frame: Baseline to 3
years]
Definition of success:
A "successful implant" is an implant where all of the following success criteria (according to
Buser et al., 1992) apply:
●
Absence of persisting subjective discomfort such as pain, foreign body perception and/or
dysesthesia (painful sensation);
●
Absence of recurrent peri-implant infection with suppuration;
●
Absence of tactile implant mobility;
●
Absence of a continuous peri-implant radiolucency.
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Definition of Survival:
Any implant present in the mouth at the moment of evaluation.
3.13. Eligibility
Study Population:
Patients that needed a tooth replacement that fulfilled the eligibility criteria.
Sampling Method:
Non-Probability Sample
Minimum Age:
18 Years
Maximum Age:
80 Years
Sex:
All
Gender Based:
No
Accepts Healthy Volunteers:
Yes
Criteria:
Inclusion Criteria:
• Patients that have received the studied ceramic implant after 27 August 2020.
• Patients of CeraRoot Clinic (Barcelona)
• Age >18
• Single or multiple missing or hopeless teeth
Exclusion Criteria:
• Smokers.
• The patient is taking medications or having treatments which have an
effect on healing in general (e.g. steroids, large doses of anti-inflammatory drugs).
• Untreated periodontal conditions
3.14. Contacts/Locations
Study Officials: Dr. Josep Oliva-Ochoa , Dr. Xavi Oliva-Ochoa
Locations: CeraRoot CLINIC. Les Franqueses del Vallès, Barcelona, Spain, 08520
4.Materials and Methods
4.1. Main product used:
CeraRoot ceramic implant
4.2. Secondary products used:
CeraRoot rotary instruments
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Protocol PMCF #200806
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CeraRoot accessories surgical
CeraRoot accessories prosthetics
4.3. Method
A patient history revision of dental charts is done by searching in the database patients with
CeraRoot implants placed during the period of this study at CeraRoot CLINIC.
An excel sheet database is done with the patients that are compatible with the inclusion criteria.
The statistical analysis is performed with the database.
4.4. Sample Size Calculation
The sample size calculation has been performed with the assumption that the results of this
study will be similar to those obtained in scientific literature with the same device which is around
98% (Oliva 2010).
The chosen statistical test and sample size equation for this clinical study is:
Formula:
Source: The-Medical-Device-Sample-Size-Cookbook.pdf
Z values taken from this source.
The inputs required for this calculation are defined below
VARIABLE
VALUE
CLARIFICATION
n
?
the sample size
P
2% (0,02)
This is called the True Proportion, i.e. the proportion to be tested. We
assume that 2% of implants will fail to integrate.
P0
3% (0,03)
This is called the Null Hypothesis Proportion. It’s the reference value (gold
standard) we are testing up against, and thus not assumed but originating
from the literature
P - P0
1% (0,01)
The minimum clinically meaningful effect, i.e. the difference between the two
proportions - which makes it interesting to test for equivalence.interesting to
test.
δ (Delta)
8% (0,08)
The testing margin, if the difference in failures is 6% or more, it’s not
considered equivalent from a clinical perspective.
H0 (Null
Hypothesis)
| P - P0 | ≥δ
The difference between the two proportions is 6% or higher. This would
mean that it’s not equivalent.
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H1
(Alt.Hypothesi
s)
| P - P0 | < δ
The difference between the two proportions is less than 6%, and thus
equivalent.
α (Alpha)
5% (0,05)
The recommended minimum standard (can be lower)
Power (1 - β)
80% (β =
0,20)
The recommended minimum standard (can be higher)
The inputs in the formula are:
n = 0,02 * (1 - 0,02) * ( ( 1,645 + 1,282) / ((0,02-0,03)-0,08))2 = 20,729 >> 21
This is, that we would need at least 21 subjects to illustrate equivalence of results of this
clinical study versus the previous CeraRoot study (PMCF #191220). For this reason the
estimated sample size of 200 patients for the present study PMCF 200806 is more than
sufficient based on this statistical calculation.
5.Scientific Background
5.1. References:
●
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. PubMed
21806681
●
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. PubMed
22519944
●
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. PubMed 22335358
●
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. PubMed 23748325
●
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. PubMed 24112624
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Protocol PMCF #200806
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●
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. Review. PubMed 27217032
●
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. PubMed 20369093
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