Prospective Observational Study of SynCone® Concept

Phase 1

• Conditions: Jaw, Edentulous
• Interventions: Procedure: Tapered abutment connection

• Registration Number: NCT03957265
• Lead Sponsor: Marcio Zaffalon Casati

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.

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).

Study Timeline

• Study First Submitted: 2019-05-17
• Study First Submitted QC: 2019-05-20
• Study First Posted: 2019-05-21
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-10
• Study Start: 2021-03-03
• Primary Completion: 2021-09-17
• Study Completion: 2022-03-17

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Syncone	Tapered abutment connection	Tapered abutment connection

Primary Outcome Measures

Name	Time	Method
Modified Gingival Index	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

Name	Time	Method
Modified Plaque Index	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.
Microbiological assays	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
Concentration of osteoimmuneinflammatory mediators	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)
Crestal bone level	6 months	Periapical radiographs will be made to evaluate crestal bone level alteration.
Oral Healthy Impact Profile-14 (OHIP-14)	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).

Trial Locations

Locations (1)

School of dentistry - Paulista University UNIP; 🇧🇷 São Paulo, SP, Brazil