Soi TS3 Surface in Patients With and Without Type 2 Diabetes

Università degli Studi di Sassari

Status

Not yet enrolling

Conditions

Dental Implant

Dental Implant-Abutment Design

Treatments

Device: Implant placement with soi surface in healthy subjects

Device: Implant placement with soi surface in diabetic subjects

Study type

Interventional

Funder types

Other

Identifiers

NCT06286566

UNISS_PHD_Osstem_2

Details and patient eligibility

About

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.

Enrollment

84 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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 periodontitis.
Patients with poor oral hygiene and motivation.
Previous guided bone reconstruction at the intended implant sites.
Uncontrolled diabetes (except for type two diabetes in test group).
Pregnancy or nursing.
Substance abuser.
Psychiatric problems or unrealistic expectations.
Lack of opposite occluding dentition in the area intended for implant placement.
Patients with infection and or inflammation in the area intended for implant placement.
Patients participating in other studies, if the present protocol cannot be properly adhered to.
Patients referred only for implant placement and cannot be followed ant the treating centre.
Patients unable to be followed for 5 years.