NCT05847907Not yet recruiting
RCT KS-SA Versur KS-BA in Diabetic Patients
Comparison of Osstem KS SA Versus KS BA for the Patient With Type 2 Diabetes: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 8 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The aim of this randomized controlled trial is to evaluate whether is better to place KS Osstem Implants with BA or SA surface placed in patients with type 2 diabetes, and to compare clinical and radiographic data.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 27 Apr 2023
- Start date
- 30 Apr 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Università degli Studi di Sassari
- Diseases
- Type 2 diabetes
- NCT number
- NCT05847907
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 30 Apr 2023 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 4 months before being treated in the study.
- Patients with controlled type 2 diabetes mellitus with a duration of at least 1 years of disease evaluation and baseline glycated hemoglobin A1c (HbA1c) values between 7.5% and 12% at the time of implant placement will be included.
Age in the registry: 18 years to - · Sex: All · Does not accept 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.