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Prospective Observational Study of SynCone® Concept

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ClinicalTrials.gov Identifier: NCT03957265
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
Dentsply Sirona Implants
Information provided by (Responsible Party):
Marcio Zaffalon Casati, Paulista University

Brief 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.

Condition or disease Intervention/treatment Phase
Jaw, Edentulous Procedure: Tapered abutment connection Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Observational Study of SynCone® Concept: Patient-related Outcomes, Clinical, Radiographic, Immunoinflammatory Mediators and Microbiological Analysis
Estimated Study Start Date : May 17, 2019
Estimated Primary Completion Date : May 17, 2020
Estimated Study Completion Date : May 17, 2021

Arm Intervention/treatment
Experimental: Syncone
Tapered abutment connection
Procedure: Tapered abutment connection
Rehabilitation of completely edentulous patients with overdentures prostheses.




Primary Outcome Measures :
  1. Modified Gingival Index [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Modified Plaque Index [ Time Frame: 6 months ]
    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.

  2. Oral Healthy Impact Profile-14 (OHIP-14) [ Time Frame: 6 months ]
    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).

  3. Microbiological assays [ Time Frame: 6 months ]
    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

  4. Concentration of osteoimmuneinflammatory mediators [ Time Frame: 6 months ]
    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)

  5. Crestal bone level [ Time Frame: 6 months ]
    Periapical radiographs will be made to evaluate crestal bone level alteration.



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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03957265


Contacts
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Contact: marcio casati 55 11 981625664 mzcasati@gmail.com

Locations
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Brazil
School of dentistry - Paulista University UNIP Recruiting
São Paulo, SP, Brazil
Contact: Fernanda V Ribeiro, Professor    55 11 71388342    fernanda@ribbeiro.com   
Sponsors and Collaborators
Marcio Zaffalon Casati
Dentsply Sirona Implants

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Responsible Party: Marcio Zaffalon Casati, professor, Paulista University
ClinicalTrials.gov Identifier: NCT03957265     History of Changes
Other Study ID Numbers: 79380717.4.0000.5512
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Jaw, Edentulous
Jaw Diseases
Musculoskeletal Diseases
Stomatognathic Diseases
Mouth, Edentulous
Mouth Diseases
Tooth Diseases