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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | 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. |
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| Control Group | Active Comparator | In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich fibrin ( PRF) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Pain: VAS | 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 weeks. |
| Post-operative Discomfort | 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. | 2 weeks |
| Post-operative Stress | 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. | 2 weeks |
| Post-operative Inability to Chew |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano | Milan | Milano | 20142 | Italy |
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42 subjects were selected from those seeking care at the Department of oral surgery, Dental clinic G.Vogel, San Paolo hospital,Milan.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2017 | Sep 24, 2018 |
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| hemostatic agents with oxidized and regenerated cellulosa | Drug | In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0). |
|
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.
| 2 weeks |
| FG001 | 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). |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Pain: VAS | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks. |
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| Primary | Post-operative Discomfort | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Post-operative Stress | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks |
| |||||||||||||||||||||||||||||||
| Primary | Post-operative Inability to Chew | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 2 weeks |
|
90 days after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 21 | 0 | 21 | 0 | 21 |
| EG001 | 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). | 0 | 21 | 0 | 21 | 0 | 21 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Fulvio Gatti | Azienda Ospedaliera San Paolo - Università degli Studi di Milano | 3396441920 | fudy@libero.it |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2017 | Sep 25, 2018 | SAP_002.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D005889 | Gingival Recession |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D055093 | Periodontal Atrophy |
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| ID | Term |
|---|---|
| D006487 | Hemostasis |
| ID | Term |
|---|---|
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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| Between 18 and 65 years |
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| >=65 years |
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| 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). |
|
|
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).
|
|
| 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). |
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