Soi TS3 Surface in Patients With and Without Type 2 Diabetes

Launched by UNIVERSITÀ DEGLI STUDI DI SASSARI · Feb 21, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to compare two groups of patients—those with type 2 diabetes and those without—who need dental implants. The researchers want to see how well a specific type of dental implant, called the Osstem implant with a SOI surface, performs in both groups. This study aims to gather important information about how these implants work for different patients, which could help improve dental care for everyone, especially those with diabetes.

To participate, patients must be at least 18 years old and have lost at least one tooth in either the upper or lower jaw. They will need to be in good health overall, with some specific requirements depending on their diabetes status. For example, patients with diabetes should have their condition under control, while those without diabetes should show no signs of it. Participants can expect to have their dental implants placed and will be followed for up to five years to monitor how well the implants work. It’s important to know that this study is not yet recruiting participants, so interested individuals may need to wait before applying.

Gender

ALL

Eligibility criteria

• 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.