Prospective Observational Study of SynCone® Concept

Jaw, Edentulous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03957265
• Other study ID #: 79380717.4.0000.5512
• Status: Recruiting
• Phase: Phase 1
• Start date: March 3, 2021
• Est. completion date: March 17, 2022

Study information

• Verified date: November 2020
• Source: Paulista University
• Contact: marcio casati
• Phone: 55 11 981625664
• Email: mzcasati[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: March 17, 2022
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Jaw, Edentulous

Intervention

Procedure:
• Tapered abutment connection
Rehabilitation of completely edentulous patients with overdentures prostheses.

Locations

Country	Name	City	State
Brazil	School of dentistry - Paulista University UNIP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Marcio Zaffalon Casati	Dentsply Sirona Implants

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Concentration of osteoimmuneinflammatory mediators	Levels of osteoimmuneinflammatory mediators will be determined in the peri-implant fluid (IL-4, IL-17, IL-1ß, IL-10, IL-6, IL-8, IL-23 and TNF-a)	6 months
Secondary	Crestal bone level	Periapical radiographs will be made to evaluate crestal bone level alteration.	6 months