dental implant placement: Comparing the amount and type of biofilm on zirconia vs. titanium implants
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
total amount of biofilm — 12 months 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.
Trial sites (1)
Facility
City
Region
Status
Complutense University of Madrid
Madrid
Madrid
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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