Biofilm Accumulation in Zirconia vs. Titanium Implants
Recruiting now · Not applicable
Conditions studied: Implant Infection
In brief
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.
Key facts
- Study ID
- NCT06075017
- Run by
- Universidad Complutense de Madrid
- People needed
- 40
- Starts
- 2027-12-01
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- Systemic pathology that contraindicates the surgical procedure: hepatitis or other infectious diseases, oncological treatment, untreated or uncontrolled systemic pathology: diabetes mellitus, arterial hypertension, osteoporosis, heart failure, valvular heart disease, history of endocarditis, acute myocardial infarction less than 6 months ago, stroke less than 6 months ago, history of venous thromboembolism, arrhythmias, vitamin D deficiency, Parkinson's and Alzheimer's disease, dementia, psychiatric disorders, liver disease, COPD, chronic renal failure, immunosuppressed, autoimmune diseases, inflammatory bowel disease, digestive pathology, phosphocalcium metabolism diseases, hyper- or hypothyroidism, endocrinopathies, celiac disease, collagenosis, etc.
- Pharmacological treatment with anticoagulants, antiaggregants, bisphosphonates, monoclonal antibodies, serotonin reuptake inhibitors, immunosuppressants, corticosteroids, antipsychotics.
Where it is running
- Complutense University of Madrid — Madrid, Madrid, Spain (enrolling)
Full record on ClinicalTrials.gov
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