Clinical trial NCT06286566: Soi TS3 Surface in Patients With and Without Type 2 Diabetes
Official title: Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Dental Implant-Abutment Design
Keywords: Dental Implant
Diabetics Patients
SOI Surface
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Melodia, Dario, M.D.
name: Pisano, Milena, M.D.
name: Dr. Aurea M. I. Lumbau
name: Prof. Silvio Mario Meloni
name: Prof. Edoardo Baldoni
First posted: 2024-02-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter prospective cohort study
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Number of prosthesis failure:
timeFrame: Up to 5 years
measure: Number of implant failure
timeFrame: Up to 5 years
measure: Number of complication
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of peri-implant marginal bone level changes
timeFrame: At 1,3 and 5 years
measure: Valuation of patient satisfaction
timeFrame: At 1,3 and 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Marco Tallarico
state: Sassari
Study officials:
References: