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RCT KS-SA Versur KS-BA in Diabetic Patients

ConditionsDental ImplantDiabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

- 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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: BA Surface test groupExperimental treatment 1 intervention
Group B: SA Surface control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 5 years
2

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.

Time frame
Up to 5 years
3

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.

Time frame
Up to 5 years

Secondary outcomes

1

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.

Time frame
At 1,3 and 5 years
2

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"

Time frame
At 1,3 and 5 years
3

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.

Time frame
1,3 and 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Università degli Studi di Sassari

Lead sponsor

Melodia, Dario, M.D.

Collaborator

Pisano, Milena, M.D.

Collaborator

Dr. Aurea M. I. Lumbau

Collaborator

Meloni, Silvio Mario, M.D.

Collaborator

Baldoni, Edoardo, M.D.

Collaborator

Source ClinicalTrials.gov

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