RCT Comparing KS Versus TS for Ovedenture

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversità degli Studi di Sassari

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Implant placement with 3.5 mm diameter KS implants.
  • Implant placement with 3.5 mm diameter TS implants.

Treatment groups

48 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Università degli Studi di Sassari

Lead sponsor

Melodia, Dario, M.D.

Collaborator

Pisano, Milena, M.D.

Collaborator

Dr. Aurea Lumbau

Collaborator

Meloni, Silvio Mario, M.D.

Collaborator

Baldoni, Edoardo, M.D.

Collaborator