Menu
Not yet recruiting NCT05847907

RCT KS-SA Versur KS-BA in Diabetic Patients

No phase Interventional Dental Implant Diabetes

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.
Who it may be relevant to
Registry conditions: Dental Implant, Diabetes. 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 KS SA Versus KS BA for the Patient With Type 2 Diabetes: A Randomized Controlled Trial

Overview

The aim of this randomized controlled trial is to evaluate whether is better to place KS Osstem Implants with BA or SA surface placed in patients with type 2 diabetes, and to compare clinical and radiographic data.

Interventions

  • Device Implant placement
    Implant placement in subject with type 2 diabetes mellitus. Implant placement in subjects with type 2 diabetes mellitus. Implants with BA surface will be placed in one group of subjects and implants with SA surface in the other group.

Primary outcome measures

  • Implant failure [Time frame: Up to 5 years]
  • Prosthesis failure [Time frame: Up to 5 years]
  • Complications [Time frame: Up to 5 years]
Secondary outcome measures (3)
  • Peri-implant marginal bone level changes [Time frame: At 1,3 and 5 years]
  • Patient satisfaction [Time frame: At 1,3 and 5 years]
  • Implant stability quotient (ISQ) [Time frame: 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 4 months before being treated in the study.
  • Patients with controlled type 2 diabetes mellitus with a duration of at least 1 years of disease evaluation and baseline glycated hemoglobin A1c (HbA1c) values between 7.5% and 12% at the time of implant placement 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: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Marco Tallarico — Rome

Identifiers

NCT: NCT05847907 · UNISS_PHD_Osstem_6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗