RCT KS-SA Versur KS-BA in Diabetic Patients

Università degli Studi di Sassari

Status: Not yet enrolling

Conditions: Diabetes; Dental Implant

Treatments: Device: Implant placement

Study type: Interventional

Funder types: Other

Identifiers

NCT05847907

UNISS_PHD_Osstem_6

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 2 patient groups

BA Surface test group

Experimental group

Description:

Common procedures: Implants placement in subjects with type 2 diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. Test procedure: use of implant with BA surface in type 2 diabetic patients.

Treatment:

Device: Implant placement

SA Surface control group

Active Comparator group

Description:

Common procedures: Implants placement in subjects with type 2 diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. Control procedure: use implant with SA surface in type 2 diabetic patients

Treatment:

Device: Implant placement