Compares dental implants with a new surface in people with and without diabetes
Tests dental implants with a SOI surface in adults with and without type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Soi TS3 Surface in Patients With and Without Type 2 Diabetes
Key facts
- Where
- Rome, ItalySee the site
Where in Italy
- Marco TallaricoRome, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Università degli Studi di Sassari
- Trial code
- NCT06286566
- Record updated
- 29 February 2024
- Original description
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.Read full original descriptionShow less
Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study
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.
Inclusion: 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: Patients treated or under treatment with intravenous amino-bisphosphonates; Previous guided bone reconstruction at the intended implant sites; Lack of opposite occluding dentition in the area intended for implant placement; Patients referred only for implant placement and cannot be followed ant the treating centre; General contraindications to implant surgery (except for type two diabetes in test group); Immunosuppressed or immunocompromised patients (except for type two diabetes in test group); Uncontrolled diabetes (except for type two diabetes in test group); Psychiatric problems or unrealistic expectations; Patients with infection and or inflammation in the area intended for implant placement; Patients irradiated in the head and neck area; Patients with untreated periodontitis; Patients with poor oral hygiene and motivation; Pregnancy or nursing; Substance abuser; Patients participating in other studies, if the present protocol cannot be properly adhered to; Patients unable to be followed for 5 years.