RCT KS-SA Versur KS-BA in Diabetic Patients
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari
About this trial
The aim of this randomized controlled trial is to evaluate whether is better to place KS Osstem Implants with BA or SA surface placed in patients with type 2 diabetes, and to compare clinical and radiographic data.
Eligibility criteria
Qualifiers
- Patients of at least 18 years old able to sign an informed consent.
Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length.
Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day).
Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery.
Disqualifiers
General contraindications to implant surgery (except for type two diabetes in test group).
Patients irradiated in the head and neck area.
Immunosuppressed or immunocompromised patients (except for type two diabetes in test group).
Patients treated or under treatment with intravenous amino-bisphosphonates.
Trial design
Treatments tested in this trial
- Implant placement
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Università degli Studi di Sassari
Lead sponsor
Melodia, Dario, M.D.
Collaborator
Pisano, Milena, M.D.
Collaborator
Dr. Aurea M. I. Lumbau
Collaborator
Meloni, Silvio Mario, M.D.
Collaborator
Baldoni, Edoardo, M.D.
Collaborator
Source ClinicalTrials.gov