Soi TS3 Surface in Patients With and Without Type 2 Diabetes

Dental Implant Clinical Trial

Official title:

Comparison of Osstem TS3 With SOI Surface in Patients With and Without Type 2 Diabetes: A Multicenter Prospective Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286566
• Other study ID #: UNISS_PHD_Osstem_2
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: January 31, 2028

Study information

• Verified date: February 2024
• Source: Università degli Studi di Sassari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this prospective cohort study is to compare clinical and radiographic data of Osstem implants with SOI surface placed in patients with or without diabetes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: January 31, 2028
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 3 months before being treated in the study.

• Only in the test group, patients with controlled type 2 diabetes mellitus with at least 2 years of disease evaluation of HbA1C values between 6% and 10 % at the time of implant placement will be included.

• Only in the control group, healthy patients without any sign of type 2 diabetes mellitus 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.

Related Conditions & MeSH terms

• Dental Implant

Intervention

Device:
• Implant placement with soi surface in diabetic subjects
Implants placement with SOI surface in subjects with diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.
• Implant placement with soi surface in healthy subjects
Implants placement with SOI surface in subjects without diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. After osseointegration implants will receive definitive prosthesis.

Locations

Country	Name	City	State
Italy	Marco Tallarico	Rome	Sassari

Sponsors (6)

Lead Sponsor	Collaborator
Università degli Studi di Sassari	Dr. Aurea M. I. Lumbau, Dr. Dario Melodia, Dr. Milena Pisano, Prof. Edoardo Baldoni, Prof. Silvio Mario Meloni

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of 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
Primary	Number of 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.	Up to 5 years
Primary	Number of complication	Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered	Up to 5 years
Secondary	Rate of peri-implant marginal bone level changes	eri-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
Secondary	Valuation of 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