Jaw, EdentulousPhase 1NCT03957265
Prospective Observational Study of SynCone® Concept
A Phase 1 study testing Tapered abutment connection in people with Jaw, Edentulous, run by Marcio Zaffalon Casati at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 40 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- Tapered abutment connection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2021to 17 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject has total edentulous maxilla.
- subject whose dental extractions occurred at least 6 months before treatment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
School of dentistry - Paulista University UNIP
São Paulo, São Paulo
Fernanda V Ribeiro, Professor, 55 11 71388342, fernanda@ribbeiro.com
About this study
Official title: Prospective Observational Study of SynCone® Concept: Patient-related Outcomes, Clinical, Radiographic, Immunoinflammatory Mediators and Microbiological Analysis
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.
Read the 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).
- Conditions
- Jaw, Edentulous
- Being tested
- Tapered abutment connection
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tapered abutment connectionProcedure or surgery
Rehabilitation of completely edentulous patients with overdentures prostheses.
| Study group | Role | What they receive |
|---|---|---|
| Syncone | Experimental | Tapered abutment connection Receives: Procedure: Tapered abutment connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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).
Measured: 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
Measured: 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)
Measured: 6 months
Crestal bone level
Periapical radiographs will be made to evaluate crestal bone level alteration.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start3 Mar 2021 (estimated)
- Primary completion17 Sep 2021 (estimated)
- Study completion17 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marcio Zaffalon Casati
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Sponsor-investigator, Marcio Zaffalon Casati, Paulista University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957265
- Sponsor's protocol ID
- 79380717.4.0000.5512
- Status last verified
- Nov 2020
- First submitted
- 17 May 2019
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of SynCone® Concept: Patient-related Outcomes, Clinical, Radiographic, Immunoinflammatory Mediators and Microbiological Analysis
- ClinicalTrials.gov ID
- NCT03957265
- Acronym / sponsor ID
- 79380717.4.0000.5512
- Conditions
- Jaw, Edentulous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Marcio Zaffalon CasatiUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 3 Mar 2021 (estimated)
- Primary completion
- 17 Sep 2021 (estimated)
- Study completion
- 17 Mar 2022 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syncone | Experimental | Procedure: Tapered abutment connectionTapered abutment connection |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject has total edentulous maxilla.
- subject whose dental extractions occurred at least 6 months before treatment.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tapered abutment connectionRehabilitation of completely edentulous patients with overdentures prostheses. | Procedure or surgery | Syncone |
Primary outcome
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
5 secondary outcomes
Modified Plaque Index
Time frame: 6 months
Oral Healthy Impact Profile-14 (OHIP-14)
Time frame: 6 months
Microbiological assays
Time frame: 6 months
Concentration of osteoimmuneinflammatory mediators
Time frame: 6 months
Crestal bone level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tapered abutment connection in people with Jaw, Edentulous, run by Marcio Zaffalon Casati at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact marcio casati (55 11 981625664, mzcasati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Gingival Index (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.