Prospective Observational Study of SynCone® Concept
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2019
CompletedFirst Posted
Study publicly available on registry
May 21, 2019
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2022
CompletedNovember 10, 2020
November 1, 2020
7 months
May 17, 2019
November 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Modified Plaque Index
6 months
Oral Healthy Impact Profile-14 (OHIP-14)
6 months
Microbiological assays
6 months
Concentration of osteoimmuneinflammatory mediators
6 months
Crestal bone level
6 months
Study Arms (1)
Syncone
EXPERIMENTALTapered abutment connection
Interventions
Rehabilitation of completely edentulous patients with overdentures prostheses.
Eligibility Criteria
You may qualify if:
- subject has total edentulous maxilla.
- subject whose dental extractions occurred at least 6 months before treatment.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marcio Zaffalon Casatilead
- Dentsply Sirona Implants and Consumablescollaborator
Study Sites (1)
School of dentistry - Paulista University UNIP
São Paulo, São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
May 17, 2019
First Posted
May 21, 2019
Study Start
March 3, 2021
Primary Completion
September 17, 2021
Study Completion
March 17, 2022
Last Updated
November 10, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share