Soi TS3 Surface in Patients With and Without Type 2 Diabetes

NCT06286566 | Not Yet Recruiting

• 1 other identifier: UNISS_PHD_Osstem_2
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Dental Implant-Abutment Design

Keywords

Dental Implant; Diabetics Patients; SOI Surface

Outcome Measures

Primary Outcomes (3)

• Number of prosthesis failure:

  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

  Up to 5 years

• Number of implant failure

  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.

  Up to 5 years

• Number of complication

  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

  Up to 5 years

Secondary Outcomes (2)

• Rate of peri-implant marginal bone level changes

  At 1,3 and 5 years

• Valuation of patient satisfaction

  At 1,3 and 5 years

Study Arms (2)

Diabetics group

EXPERIMENTAL

Group of subjects with diabetes who will be inserted implants with a new implant surface called SOI

Device: Implant placement with soi surface in diabetic subjects

Healthy Group

ACTIVE COMPARATOR

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

Device: Implant placement with soi surface in healthy subjects

Interventions

Implant placement with soi surface in diabetic subjects DEVICE

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.

Diabetics group

Implant placement with soi surface in healthy subjects DEVICE

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.

Healthy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead
• Melodia, Dario, M.D.: collaborator
• Pisano, Milena, M.D.: collaborator
• Dr. Aurea M. I. Lumbau: collaborator
• Prof. Silvio Mario Meloni: collaborator
• Prof. Edoardo Baldoni: collaborator

Study Sites (1)

Marco Tallarico

Rome, Sassari, 07100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: centralized radiographic assessor, outcome assessors(when possible), and the statistical advisors will be blind to the used implants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Model Details: Multicenter prospective cohort study

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: February 29, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): January 31, 2028
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)