Soi TS3 Surface in Patients With and Without Type 2 Diabetes (NCT06286566) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Soi TS3 Surface in Patients With and Without Type 2 Diabetes
Italy84 participantsStarted 2024-03-01
Plain-language summary
The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.
* Only in the test group, patients with controlled type 2 diabetes mellitus with at least 2 years of disease evaluation of HbA1C values between 6% and 10 % at the time of implant placement will be included.
* Only in the control group, healthy patients without any sign of type 2 diabetes mellitus will be included
Exclusion Criteria:
* 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.
* Patients with untreated per…