Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Number of complication
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
centralized radiographic assessor, outcome assessors(when possible), and the statistical advisors will be blind to the used implants
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Number of complication
Time Frame: Up to 5 years
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered
Number of implant failure
Time Frame: Up to 5 years
defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable.
Number of prosthesis failure:
Time Frame: Up to 5 years
whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason
Secondary Outcomes
- Valuation of patient satisfaction(At 1,3 and 5 years)
- Rate of peri-implant marginal bone level changes(At 1,3 and 5 years)
Investigators
Marco Tallarico
Assistent Professor
Università degli Studi di Sassari