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Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage

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ClinicalTrials.gov Identifier: NCT03685396
Recruitment Status : Completed
First Posted : September 26, 2018
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Eliam Scaramuzza, Azienda Ospedaliera San Paolo

Brief Summary:
This study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous PRF (Platelet Rich Fibrin) membranes to cover the donor site.In the Test Group venous blood sampling was done in order to prepare PRF membranes used to cover the donor site, whereas in Control Group hemostatic agents with oxidized and regenerated cellulosa were used.

Condition or disease Intervention/treatment Phase
Postoperative Pain Postoperative Complications Gingival Recession Biological: Platelet rich fibrin ( PRF) Drug: hemostatic agents with oxidized and regenerated cellulosa Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage: a Comparative Randomized Clinical Trial
Actual Study Start Date : November 27, 2017
Actual Primary Completion Date : July 23, 2018
Actual Study Completion Date : September 9, 2018

Arm Intervention/treatment
Experimental: 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.
Biological: 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.


Active Comparator: Control Group
In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.
Drug: 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).




Primary Outcome Measures :
  1. Post-operative Pain: VAS [ Time Frame: 2 weeks. ]
    The patient morbidity was evaluated with a questionnaire given to patients 1 week following surgery considering parameters such as post-operative pain, discomfort, bleeding, stress and inability to chew. The questionnaire included the evaluation of the intensity of these parameters on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of pain by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of pain, whereas the end-point at 100mm corresponded to the worst level of pain felt in life. Then the point indicated by the patient was measured in millimeters.

  2. Post-operative Discomfort [ Time Frame: 2 weeks ]
    Discomfort was defined as the level of soreness experienced by the patients during the first post-operative week due to the palatal wound and how it influenced the ability to work and the quality of the sleep. The questionnaire included the evaluation of the intensity of post-operative discomfort on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of discomfort by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of discomfort whereas the end-point at 100mm corresponded to the worst possible discomfort . Then the point indicated by the patient was measured in millimeters.

  3. Post-operative Stress [ Time Frame: 2 weeks ]
    Stress was related to the level of apprehension and fear experienced by the patients of jeopardizing the palatal wound. The questionnaire included the evaluation of the intensity of post-operative stress on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of stress by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of stress whereas the end-point at 100mm corresponded to the worst possible stress . Then the point indicated by the patient was measured in millimeters.

  4. Post-operative Inability to Chew [ Time Frame: 2 weeks ]

    Inability to chew was described as the level of variation of the patients' eating habits due to the presence of the palatal wound.

    The questionnaire included the evaluation of the intensity of post-operative inability to chew on a Visual Analogical Scale (VAS) of 100 mm. Patients had to show their level of inability to chew by indicating a position along a continuous line of 100mm between two end-points. The 0 end-point corresponded to abscence of changes in their eating habits whereas the end-point at 100mm corresponded to the worst possible inability to chew. Then the point indicated by the patient was measured in millimeters.




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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • FMPS (Full Mouth Plaque Score) and FMBS (Full Mouth Bleeding Score) < 20%,
  • presence of two adjacent Miller's Class I and II recession defects on natural teeth (≥ 2mm in depth);

Exclusion Criteria:

  • contraindications for periodontal surgery
  • 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.

Information from the National Library of Medicine

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): NCT03685396


Locations
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Italy
Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano
Milan, Milano, Italy, 20142
Sponsors and Collaborators
Azienda Ospedaliera San Paolo
  Study Documents (Full-Text)

Documents provided by Eliam Scaramuzza, Azienda Ospedaliera San Paolo:
Study Protocol  [PDF] September 29, 2017
Statistical Analysis Plan  [PDF] September 29, 2017


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Responsible Party: Eliam Scaramuzza, Principal investigator, Azienda Ospedaliera San Paolo
ClinicalTrials.gov Identifier: NCT03685396     History of Changes
Other Study ID Numbers: PRF
First Posted: September 26, 2018    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eliam Scaramuzza, Azienda Ospedaliera San Paolo:
Connective tissue graft
Platelet concentrates
PRF
Mucogingival surgery
Additional relevant MeSH terms:
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Gingival Recession
Postoperative Complications
Pathologic Processes
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy
Hemostatics
Coagulants