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 : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Jaw, Edentulous||Procedure: Tapered abutment connection||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Observational Study of SynCone® Concept: Patient-related Outcomes, Clinical, Radiographic, Immunoinflammatory Mediators and Microbiological Analysis|
|Estimated Study Start Date :||October 17, 2019|
|Estimated Primary Completion Date :||May 17, 2020|
|Estimated Study Completion Date :||May 17, 2021|
Tapered abutment connection
Procedure: Tapered abutment connection
Rehabilitation of completely edentulous patients with overdentures prostheses.
- 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
- 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.
- 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).
- 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
- 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)
- Crestal bone level [ Time Frame: 6 months ]Periapical radiographs will be made to evaluate crestal bone level alteration.
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
|Contact: marcio casati||55 11 firstname.lastname@example.org|
|School of dentistry - Paulista University UNIP||Recruiting|
|São Paulo, SP, Brazil|
|Contact: Fernanda V Ribeiro, Professor 55 11 71388342 email@example.com|