Actively Recruiting
Biofilm Accumulation in Zirconia vs. Titanium Implants
Led by Universidad Complutense de Madrid · Updated on 2026-05-08
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Biofilm Accumulation in Zirconia vs. Titanium Implants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients of both sexes aged 18 years or older
- Patients classified as ASA I, II, or III
- Patients requiring placement of a single implant
- Patients who agree to surgery and provide informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Patients unable to attend follow-up appointments after surgery
- Patients with implants adjacent to the treatment area
- Patients with uncontrolled periodontal disease
- Patients with systemic conditions contraindicating surgery, including but not limited to hepatitis, infectious diseases, cancer treatment, uncontrolled diabetes, hypertension, osteoporosis, heart failure, valvular disease, recent myocardial infarction or stroke, venous thromboembolism, arrhythmias, vitamin D deficiency, neurological disorders (Parkinson's, Alzheimer's, dementia), psychiatric disorders, liver disease, COPD, chronic kidney failure, immunosuppression, autoimmune or inflammatory bowel diseases, metabolic or endocrine disorders, celiac disease, collagen diseases
- Patients taking anticoagulants, antiaggregants, bisphosphonates, monoclonal antibodies, serotonin reuptake inhibitors, immunosuppressants, corticosteroids, or antipsychotics
AI-Screening
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Trial Site Locations
Total: 1 location
1
Complutense University of Madrid
Madrid, Madrid, Spain, 28040
Actively Recruiting
Research Team
J
Jorge JC Cortés-Bretón, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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