Menu
Not yet recruiting NCT06286566

Soi TS3 Surface in Patients With and Without Type 2 Diabetes

No phase Interventional Dental Implant Dental Implant-Abutment Design

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implant placement with soi surface in diabetic subjects, Implant placement with soi surface in healthy subjects.
Who it may be relevant to
Registry conditions: Dental Implant, Dental Implant-Abutment Design. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study

Overview

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.

Interventions

  • Device 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.
  • Device 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.

Primary outcome measures

  • Number of prosthesis failure: [Time frame: Up to 5 years]
  • Number of implant failure [Time frame: Up to 5 years]
  • Number of complication [Time frame: Up to 5 years]
Secondary outcome measures (2)
  • Rate of peri-implant marginal bone level changes [Time frame: At 1,3 and 5 years]
  • Valuation of patient satisfaction [Time frame: At 1,3 and 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Marco Tallarico — Rome

Identifiers

NCT: NCT06286566 · UNISS_PHD_Osstem_2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗