Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage
NCT ID: NCT03685396
Last Updated: 2019-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2017-11-27
2018-09-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Test Group
In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site of the connective tissue graft.
Platelet rich fibrin ( PRF)
Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.
At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site.
Control Group
In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.
hemostatic agents with oxidized and regenerated cellulosa
In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0).
Interventions
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Platelet rich fibrin ( PRF)
Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.
At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site.
hemostatic agents with oxidized and regenerated cellulosa
In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0).
Eligibility Criteria
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Inclusion Criteria
* presence of two adjacent Miller's Class I and II recession defects on natural teeth (≥ 2mm in depth);
Exclusion Criteria
* taking medications or having diseases known to interfere with periodontal tissue health or healing and coagulation.
* smoking more than 10 cigarettes a day
* Gingival recessions on molar teeth were excluded.
18 Years
60 Years
ALL
Yes
Sponsors
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Azienda Ospedaliera San Paolo
OTHER
Responsible Party
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Eliam Scaramuzza
Principal investigator
Locations
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Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano
Milan, Milano, Italy
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PRF
Identifier Type: -
Identifier Source: org_study_id
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