Soi TS3 Surface in Patients With and Without Type 2 Diabetes
NCT ID: NCT06286566
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
84 participants
INTERVENTIONAL
2024-03-01
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Diabetics group
Group of subjects with diabetes who will be inserted implants with a new implant surface called SOI
Implant placement with soi surface in diabetic subjects
Implants placement with SOI surface in subjects with diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Healthy Group
Group of helthy subjects who will be inserted implants with a new implant surface called SOI to compare them with the group of diabetic subjects
Implant placement with soi surface in healthy subjects
Implants placement with SOI surface in subjects without diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Interventions
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Implant placement with soi surface in diabetic subjects
Implants placement with SOI surface in subjects with diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Implant placement with soi surface in healthy subjects
Implants placement with SOI surface in subjects without diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Melodia, Dario, M.D.
INDIV
Pisano, Milena, M.D.
INDIV
Dr. Aurea M. I. Lumbau
UNKNOWN
Prof. Silvio Mario Meloni
UNKNOWN
Prof. Edoardo Baldoni
UNKNOWN
Università degli Studi di Sassari
OTHER
Responsible Party
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Marco Tallarico
Assistent Professor
Locations
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Marco Tallarico
Rome, Sassari, Italy
Countries
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Other Identifiers
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UNISS_PHD_Osstem_2
Identifier Type: -
Identifier Source: org_study_id