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Prospective Observational Study of SynCone® Concept

NCT ID: NCT03957265

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-03

Study Completion Date

2022-03-17

Brief Summary

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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

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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

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Jaw, Edentulous

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Syncone

Tapered abutment connection

Group Type EXPERIMENTAL

Tapered abutment connection

Intervention Type PROCEDURE

Rehabilitation of completely edentulous patients with overdentures prostheses.

Interventions

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Tapered abutment connection

Rehabilitation of completely edentulous patients with overdentures prostheses.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role collaborator

Marcio Zaffalon Casati

OTHER

Sponsor Role lead

Responsible Party

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Marcio Zaffalon Casati

professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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School of dentistry - Paulista University UNIP

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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marcio casati

Role: CONTACT

Phone: 55 11 981625664

Email: [email protected]

Facility Contacts

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Fernanda V Ribeiro, Professor

Role: primary

Other Identifiers

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79380717.4.0000.5512

Identifier Type: -

Identifier Source: org_study_id