Clinical trial NCT05843981: Comparison KS Versus TS
Official title: The Use of an Innovative, Thickened and Lasting Implant Comparing KS Versus TS Implants for Prosthetic Rehabilitations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Dental Implant-Abutment Design
Keywords: Dental Implant-Abutment Design
KS dental implant
Implant-abutment connection
Lead sponsor: Università degli Studi di Sassari
Sponsor class: OTHER
Collaborators: name: Melodia, Dario, M.D.
name: Pisano, Milena, M.D.
name: Dr. Aurea Lumbau
name: Prof. Silvio Mario Meloni
name: Prof. Edoardo Baldoni
First posted: 2023-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with implant failure
timeFrame: Up to 5 years
measure: Number of Participants with prosthesis failure
timeFrame: Up to 5 years
measure: Number of complications
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of peri-implant marginal bone level changes
timeFrame: At 1,3 and 5 years
measure: Valuation of patient satisfaction
timeFrame: At 1,3 and 5 years
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Marco Tallarico
Study officials:
References: