RCT Comparing KS Versus TS for Ovedenture

Università degli Studi di Sassari

Status: Not yet enrolling

Conditions: Edentulous Jaw; Dental Implant; Dental Implant-Abutment Design

Treatments: Device: Implant placement with 3.5 mm diameter TS implants.; Device: Implant placement with 3.5 mm diameter KS implants.

Study type: Interventional

Funder types: Other

Identifiers

NCT06276712

UNISS_PHD_Osstem_5

Details and patient eligibility

About

To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Any edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
• 18 years or older, and able to sign an informed consent.
• 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.

Exclusion criteria

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: Single Blind

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48 participants in 2 patient groups

Ks dental implant

Experimental group

Description:

Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using KS implant with 3.5 mm of diameter

Treatment:

Device: Implant placement with 3.5 mm diameter KS implants.

TS dental implant

Active Comparator group

Description:

Implant placement in edentulous jaws for a prosthetic implant rehabilitation with implant-retained overdenture (mucosally supported), on two implants using TS implant with 3.5 mm of diameter

Treatment:

Device: Implant placement with 3.5 mm diameter TS implants.