Clinical trial NCT05847907: RCT KS-SA Versur KS-BA in Diabetic Patients
Official title: Comparison of Osstem KS SA Versus KS BA for the Patient With Type 2 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Diabetes
Keywords: Dental Implant
Diabetics Patients
Implant-abutment connection
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Melodia, Dario, M.D.
name: Pisano, Milena, M.D.
name: Dr. Aurea M. I. Lumbau
name: Prof. Silvio Mario Meloni
name: Prof. Edoardo Baldoni
First posted: 2023-05-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, randomized controlled trial.
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Implant failure
timeFrame: Up to 5 years
measure: Prosthesis failure
timeFrame: Up to 5 years
measure: Complications
timeFrame: Up to 5 years
Secondary outcomes:
measure: Peri-implant marginal bone level changes
timeFrame: At 1,3 and 5 years
measure: Patient satisfaction
timeFrame: At 1,3 and 5 years
measure: Implant stability quotient (ISQ)
timeFrame: 1,3 and 5 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Marco Tallarico
state: Sassari
Study officials:
References: