NCT03957265

Prospective Observational Study of SynCone® Concept

Prospective Observational Study of SynCone® Concept: Patient-related Outcomes, Clinical, Radiographic, Immunoinflammatory Mediators and Microbiological Analysis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Marcio Zaffalon Casati · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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).

Conditions

• Jaw, Edentulous

Interventions

Type	Name	Description
PROCEDURE	Tapered abutment connection	Rehabilitation of completely edentulous patients with overdentures prostheses.

Timeline

• Start date: 2021-03-03
• Primary completion: 2021-09-17
• Completion: 2022-03-17
• First posted: 2019-05-21
• Last updated: 2020-11-10

Locations

1 site across 1 country: Brazil