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

Study design:

The present protocol is designed as a randomized controlled clinical trial. The set of procedures of the present clinical trial will be carried out in the Master of Oral Surgery and Implantology of the Faculty of Dentistry of the Complutense University of Madrid (Spain). This study will be carried out in accordance with the principles established by the Declaration of Helsinki and will be conducted under the approval of the Clinical Trials Committee of the Hospital Clínico San Carlos of Madrid.

The selection of subjects with indication for osseointegrated implant placement will be based on a previous oral and radiological examination by means of a periapical radiograph and a panoramic radiograph and/or Cone Beam Computed Tomography , together with the completion of a clinical questionnaire.

For implant placement, a linear incision of the edentulous ridge and an intrasulcular incision of the adjacent teeth will be made using a #15 scalpel blade and a #3 Bard Parker scalpel handle. Once this is done, a full-thickness flap will be raised and the alveolar ridge will be reamed, following the manufacturer's indications, to place a titanium implant (Phibo® Aurea Evolution) of adequate dimensions in the control group or a zirconia implant (Z system®) in the test group, checking that there is an adequate insertion torque of 30Ncm or more and a cover screw will be placed. Once the implant is in place, simple stitches with supramid monofilament 4/0 suture (Proclinic®) will be placed until the wound is closed. Finally, antibiotic treatment (Amoxicillin 750mg/8hours/7 days), analgesic and anti-inflammatory (Dexketoprofen 25mg/8hours/5 days and Metamizole 575mg/8hours/if pain persists) will be prescribed to all patients. Physical anti-inflammatory measures (intermittent local icing for at least 30 minutes) and salt and water rinses 3 times a day for 7 days will be prescribed. Three months after implant placement in the mandible and four months in the maxilla, the final screw-retained metal-ceramic crown will be loaded with a transepithelial abutment made of titanium for titanium implants or zirconia for zirconia implants.

Study visits In both groups, paper-tip samples will be taken from the peri-implant sulcus before the placement of the final crown ("basal" visit), at 6 months (visit 2) and 1 year (visit 3), to perform a culture of the type and quantity of bacteria present in the placed implants. The survival of the placed implants, the probing depth of the implants, the bleeding on probing of the implants, the plaque index of the implants and the amount of keratinized gingiva from the midpoint of the vestibular gingival margin to the mucogingival line on the day of crown placement will also be evaluated at 6 and 12 months. Finally, after final crown placement, a periapical radiograph with parallelizer will be taken and repeated at 6 and 12 months to evaluate marginal bone loss, mesial and distal to the implant, using Vistasoft® 3.0.22/2023 software, calibrating the image with the length of the implant, since its dimension will be known.