Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
Healthy Volunteers
ID06075017

Comparison of Biofilm Accumulation on the Surface of Zirconia Versus Titanium Implants Randomized Controlled Pilot Clinical Trial

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

Researchers are conducting a randomized clinical trial to compare the amount and type of biofilm that forms on zirconia dental implants versus titanium dental implants. This pilot study will involve 30 patients receiving single implants, aiming to evaluate biofilm accumulation along with other factors such as bleeding on probing, plaque index, keratinized gingiva, marginal bone loss, and patient satisfaction over a 12-month period. The study follows strict ethical guidelines and uses statistical methods to analyze the data for significant differences between implant types. Participants will receive either a two-piece zirconia implant or a two-piece titanium implant to replace a single missing tooth. Implant placement involves surgical procedures including incisions, flap elevation, alveolar ridge preparation, and implant insertion, followed by antibiotic and anti-inflammatory treatments. After healing periods of three months for mandible and four months for maxilla, final screw-retained metal-ceramic crowns are placed. Evaluations occur before crown placement, at six months, and at one year. Patients will undergo sample collections from the implant site to culture bacteria and assess biofilm amounts at specified intervals. Additional assessments include implant survival, probing depth, bleeding on probing, plaque index, keratinized gingiva measurement, and radiographic evaluation of bone loss using specialized software. Data collection is carefully calibrated for reliability, and patients are monitored throughout the study duration of one year after implant placement.

CONDITIONS

Brief Title

Biofilm Accumulation in Zirconia vs. Titanium Implants

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients of both sexes who are adults (18 years or older)
  • Patients classified as ASA I, II, or III
  • Patients requiring placement of a single dental implant
  • Patients willing to accept surgery and sign informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Patients unable to attend follow-up visits after surgery
  • Patients with implants adjacent to the treatment area
  • Patients with uncontrolled periodontal disease
  • Patients with systemic conditions contraindicating surgery such as infectious diseases, oncological treatment, uncontrolled diabetes, heart conditions, recent stroke or heart attack, immunosuppression, psychiatric disorders, and several other listed systemic diseases
  • Patients on certain medications including anticoagulants, antiaggregants, bisphosphonates, monoclonal antibodies, serotonin reuptake inhibitors, immunosuppressants, corticosteroids, and antipsychotics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 4 months until final crown placement

Participants undergo placement of a zirconia or titanium dental implant to replace a single missing tooth, including surgery and post-operative care with prescribed medications and instructions.

1 surgical visit and 1 baseline visit before crown placement

Follow-up

Duration - 12 months post crown placement

Participants attend follow-up visits to assess biofilm accumulation, implant survival, probing depth, bleeding on probing, plaque index, keratinized gingiva, and marginal bone loss using radiographs at 6 and 12 months after crown placement.

2 visits (at 6 months and 12 months)

Trial Site Locations

Total: 1 location

1

Complutense University of Madrid

Madrid, Madrid, Spain, 28040

Actively Recruiting

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Research Team

J

Jorge JC Cortés-Bretón, Dr.

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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