RCT KS-SA Versur KS-BA in Diabetic Patients

NCT05847907 | Not Yet Recruiting

• 1 other identifier: UNISS_PHD_Osstem_6
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implant; Diabetes

Keywords

Dental Implant; Diabetics Patients; Implant-abutment connection

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Peri-implant marginal bone level changes

  At 1,3 and 5 years

• Patient satisfaction

  At 1,3 and 5 years

• Implant stability quotient (ISQ)

  1,3 and 5 years

Study Arms (2)

BA Surface test group

EXPERIMENTAL

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

SA Surface control group

ACTIVE COMPARATOR

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

Interventions

Implant placement DEVICE

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.

BA Surface test group; SA Surface control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Università degli Studi di Sassari: lead
• Melodia, Dario, M.D.: collaborator
• Pisano, Milena, M.D.: collaborator
• Dr. Aurea M. I. Lumbau: collaborator
• Prof. Silvio Mario Meloni: collaborator
• Prof. Edoardo Baldoni: collaborator

Study Sites (1)

Marco Tallarico

Rome, Sassari, 07100, Italy

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients, centralized radiographic assessor, outcome assessors, and the statistical advisors will be blind to the used implants
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistent Professor

Model Details: Multicenter, randomized controlled trial.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: April 30, 2023
• Primary Completion: December 31, 2024
• Study Completion (Estimated): January 30, 2028
• Last Updated: May 8, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)