Prospective Observational Study of SynCone® Concept

Study Overview
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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).

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

Conditions
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Jaw, Edentulous

Intervention / Treatment
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* Procedure: Tapered abutment connection


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Syncone<br>Tapered abutment connection | Procedure: Tapered abutment connection<br>* Rehabilitation of completely edentulous patients with overdentures prostheses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Gingival Index | Index of mucosal condition (Mombelli et al.1987): 0 - No bleeding when a periodontal probe is passed along the mucosal margin adjacent to the implant, 1 - Isolated bleeding spots visible, 2 - Blood forms a confluent red line on mucosal margin, 3 - Heavy or profuse bleeding | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Plaque Index | Index of plaque accumulation (Mombelli et al.1987): 0 - No detection of plaque, Plaque only recognized by running a probe accross the smooth marginal surface of the implant, 2 - Plaque can be seen by the naked eye, 3 - Abundance of soft matter. | 6 months | 
| Oral Healthy Impact Profile-14 (OHIP-14) | A questionnaire will be administered to evaluate patient centered outcomes with regards to prosthesis. It has 14 questions in which the patient answers between never (0), rarely (1), sometimes (2), repeatedly (3) and always (4). | 6 months | 
| Microbiological assays | Peri-implant biofilm will be collected and Real Time PCR wil be performed to measure the absolute quantification of Aggregatibacter Actinomycetemcomitans, Porphyromonas gingivalis, and Tannerella forsythensis | 6 months | 
| Concentration of osteoimmuneinflammatory mediators | Levels of osteoimmuneinflammatory mediators will be determined in the peri-implant fluid (IL-4, IL-17, IL-1β, IL-10, IL-6, IL-8, IL-23 and TNF-α) | 6 months | 
| Crestal bone level | Periapical radiographs will be made to evaluate crestal bone level alteration. | 6 months |