Comparison KS Versus TS

Dental Implant Clinical Trial

Official title:

The Use of an Innovative, Thickened and Lasting Implant Comparing KS Versus TS Implants for Prosthetic Rehabilitations

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05843981
• Other study ID #: UNISS_PHD_Osstem_1
• 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

To compare the clinical and radiographic outcomes of two different implant systems with different implant-abutment connection: Osstem TS III (control group) versus Osstem KS (study group).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• 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:

Any partially edentulous patient with partial edentulism, requiring at least two dental implant-supported rehabilitations, being 18 years or older, and able to sign an informed consent. Implant sites must allow the placement of two implants of at least 4 (premolars) or 4.5 (molars) mm of diameter and 8.5 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). In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study. Implants can be adjacent.

Exclusion Criteria:

• General contraindications to implant surgery.

• Patients irradiated in the head and neck area.

• Immunosuppressed or immunocompromised patients.

• 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.

• 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 TS III
Implant placement in subjects who have lost at least two teeth and need a prosthetic implant rehabilitation with TSIII Implant. . After osseointegration, dental implants will receive definitive prosthesis.
• Implant placement ks
Implant placement in subjects who have lost at least two teeth and need a prosthetic implant rehabilitation with KS Implant. After osseointegration, dental implants will receive definitive prosthesis.

Locations

Country	Name	City	State
Italy	Marco Tallarico	Sassari

Sponsors (6)

Lead Sponsor	Collaborator
Università degli Studi di Sassari	Dr. Aurea 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 Participants with 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
Primary	Number of Participants with 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 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	Rate of 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
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