Biofilm Accumulation in Zirconia vs. Titanium Implants
ConditionImplant Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversidad Complutense de Madrid
About this trial
The aim of this randomized clinical trial is to compare the amount and type of biofilm formed on the surface of zirconia implants compared to titanium implants.
A pilot randomized clinical trial will be conducted in which 15 zirconia and 15 titanium single implants will be placed in different patients and the amount of total biofilm and different bacterial species will be evaluated at 3, 6 and 12 months after placement, in addition to bleeding on probing, plaque index, amount of keratinized gingiva, marginal bone loss and patient satisfaction. The Shapiro-Wilk normality test will be performed to determine whether each group follows a normal distribution. Once the distribution of the samples has been verified, we will proceed to apply a parametric test of repeated measures ANOVA or mixed ANOVA with Bonferroni correction, in order to observe what changes exist in the variables to be studied and if these will be statistically significant, establishing a significance level of P\<0.05. If the distribution does not comply with normality, the nonparametric Friedman test will be performed.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients of both sexes of legal age.
Patients ASA I, II and III.
Subsequent to the placement of a single implant.
Patients who accept the surgery and sign the informed consent.
Disqualifiers
Pregnant or breastfeeding women
Patients who cannot attend follow-up appointments after surgery.
Patients with implants adjacent to the area to be treated.
Patients with uncontrolled periodontal pathology.
Trial design
Design model
Parallel
Treatments tested in this trial
dental implant placement
Procedure/SurgeryComparing the amount and type of biofilm on zirconia vs. titanium implants
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ZirconiaExperimental treatment 1 intervention
Group B: TitaniumActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
total amount of biofilm
The total amount of biofilm (CFU/ml) and the amount of A. actinomyces (CFU/ml), P. gingivalis (CFU/ml), P. intermedia (CFU/ml), T. forsythia (CFU/ml), P. micra (CFU/ml), F. nucleatum (CFU/ml), C. rectus (CFU/ml), E. corrodens (CFU/ml), Capnocytophaga sp. (CFU/ml), A. odontolyticus (CFU/ml), S. mutans (CFU/ml) and Candidae sp. (CFU/ml) on implants placed prior to crown placement, at 6 months and 1 year after final crown placement, by culturing with two sterile paper tips at the two points of greatest probing for 20 seconds each.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov