NCT06286566Not yet recruiting
Soi TS3 Surface in Patients With and Without Type 2 Diabetes
Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study
Source: ClinicalTrials.gov · Last updated 29 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 24 Apr 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Università degli Studi di Sassari
- Diseases
- Type 2 diabetes
- NCT number
- NCT06286566
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 1 Mar 2024 to the primary completion date, 31 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Marco Tallarico Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.