Prospective Observational Study of SynCone® Concept

Marcio Zaffalon Casati

Status and phase

Unknown

Phase 1

Conditions

Jaw, Edentulous

Treatments

Procedure: Tapered abutment connection

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03957265

79380717.4.0000.5512

Details and patient eligibility

About

The aim of this prospective observational study will be to evaluate patient-related outcomes, clinical, microbiological and peri-implant immunoinflammatory mediators in completely edentulous patients rehabilitated with delayed loaded overdentures prostheses. The investigators hypothetize that this system could restore edentulous patients with healthier mucosal concerning clinical, microbiological and immunoinflammatory parameters, besides to promote improvement in patient satisfaction and quality of life.

Full description

This prospective observational study will include fifteen edentulous patients rehabilitated with conventional dentures. Patients will receive four to six maxillary implants loaded three months after surgery. Clinical, microbiological and immunoinflammatory parameters will be evaluated at baseline, three, and six months following overdenture prosthesis. Patient-centered/reported outcomes concerning general satisfaction with the prostheses as well as comfort, ability to speak, stability, esthetics, ease of cleaning and occlusion, will be evaluated at baseline (conventional denture evaluation) and after 6 months (overdenture evaluation).

Enrollment

15 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

subject has total edentulous maxilla.
subject whose dental extractions occurred at least 6 months before treatment.

Exclusion criteria

pregnancy, lactation, smoking or ex-smokers, systemic conditions that could affect bone metabolism (e.g., immunologic disorders, diabetes), use of anti-inflammatory, biphosphonate, and immunosuppressive medications, subjects that required bone grafts before/during implant surgery.