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Biofilm Accumulation in Zirconia vs. Titanium Implants

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Dec 1, 2025 to Dec 1, 2027
    • Start date: Dec 1, 2024 to Dec 1, 2027
    • Study completion date: Dec 1, 2026 to Dec 1, 2028
    • Site details revised
    v4
  2. Phase: Phase 4 to Not applicable
    • Primary completion date: Dec 1, 2023 to Dec 1, 2025
    • Start date: Dec 1, 2023 to Dec 1, 2024
    • Study completion date: Dec 1, 2023 to Dec 1, 2026
    v3
  3. Phase: Not applicable to Phase 4v2 Show 4 more changesShow less
    • Start date: Oct 1, 2023 to Dec 1, 2023
    • Primary completion date: Nov 1, 2023 to Dec 1, 2023
    • Interventions: Zirconia dental implants (Procedure) to dental implant placement (Procedure)
    • Study description shortened, about 325 words
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06075017
Lead Sponsor Universidad Complutense de Madrid
Conditions
(from sponsor)		 Implant Infection
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov