Clinical Trial

Biofilm Accumulation in Zirconia vs. Titanium Implants

Recruiting
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Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-03; most recent amendment 2026-05-04.
Trial Details
NCT Number NCT06075017
Lead Sponsor Universidad Complutense de Madrid
Conditions Implant Infection
Enrollment 40 participants
Start Date 2027-12-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-08