Biofilm Accumulation in Zirconia vs. Titanium Implants

NCT06075017 | Recruiting DMC

• 1 other identifier: 109-190723
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Implant Infection

Outcome Measures

Primary Outcomes (1)

• total amount of biofilm

  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.

  12 months

Study Arms (2)

Zirconia

EXPERIMENTAL

Two-piece zirconia dental implant will be placed to replace a single missing tooth.

Procedure: dental implant placement

Titanium

ACTIVE COMPARATOR

Two-piece titanium dental implant will be placed to replace a single missing tooth.

Procedure: dental implant placement

Interventions

dental implant placement PROCEDURE

Comparing the amount and type of biofilm on zirconia vs. titanium implants

Also known as: Titanium dental implants

Titanium; Zirconia

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead

Study Sites (1)

Complutense University of Madrid

Madrid, Madrid, 28040, Spain

RECRUITING

Central Study Contacts

Jorge JC Cortés-Bretón, Dr.

CONTACT

913941966; jcortesb@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 10, 2023
• Study Start (Estimated): December 1, 2027
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)