RCT KS-SA Versur KS-BA in Diabetic Patients

Comparison of Osstem KS SA Versus KS BA for the Patient With Type 2 Diabetes: A Randomized Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Dental Implant
• Intervention / Treatment: Device: Implant placement

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Sassari
    • Rome, Sassari, Italy, 07100
      • Marco Tallarico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BA Surface test group; 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.	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.
Active Comparator: SA Surface control group; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments.	Up to 5 years
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
Complications	Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complications will be considered.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-implant marginal bone level changes	Peri-implant marginal bone level changes will be assessed on periapical radiographs took with the paralleling technique at implant placement, at initial loading, 1,3 and 5 years after loading. Ideally digital radiographs should be taken, otherwise radiographs on conventional films will be scanned into TIFF format with a 600 dpi resolution, and stored in a personal computer. Peri-implant marginal bone levels will be measured using the Scion Image (Scion Corporation, Frederick, MD, USA) software. The software will be calibrated for every single image using the known distance of the first two consecutive threads. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured.	At 1,3 and 5 years
Patient satisfaction	Patients will answer the following questions (separately for each implant): Are you satisfied with the function of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. Are you satisfied with the aesthetic outcome of your implant-supported prostheses? Possible answers: yes absolutely, yes partly, not sure, not really, absolutely not. Would you undergo the same therapy again? Possible answers: "yes" or "no"	At 1,3 and 5 years
Implant stability quotient (ISQ)	ISQ was measured and recorded using the IS3 (Osstem), at implant placement, at implants exposure, at the impression time, and prosthetic loading.	1,3 and 5 years

Collaborators and Investigators

• Sponsor: Università degli Studi di Sassari
• Collaborators: Dr. Dario Melodia; Dr. Milena Pisano; Prof. Silvio Mario Meloni; Prof. Edoardo Baldoni; Dr. Aurea M. I. Lumbau

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): January 30, 2028

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Dental Implant; Implant-abutment connection; Diabetics Patients
• Other Study ID Numbers: UNISS_PHD_Osstem_6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No