Comparison KS Versus TS

Università degli Studi di Sassari

Status: Not yet enrolling

Conditions: Dental Implant; Dental Implant-Abutment Design

Treatments: Device: Implant placement ks; Device: Implant placement TS III

Study type: Interventional

Funder types: Other

Identifiers

NCT05843981

UNISS_PHD_Osstem_1

Details and patient eligibility

About

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).

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Ks dental implant

Experimental group

Description:

Innovative dental implant with lasting, internal conical connection of 15° and strengthened implant walls.

Treatment:

Device: Implant placement ks

TSIII dental implant

Active Comparator group

Description:

Standard dental implant with internal conical connection of 11°.

Treatment:

Device: Implant placement TS III