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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Postoperative Pain
Postoperative Complications
Gingival Recession
Interventions Biological: Platelet rich fibrin ( PRF)
Drug: hemostatic agents with oxidized and regenerated cellulosa
Enrollment 42
Recruitment Details 42 subjects were selected from those seeking care at the Department of oral surgery, Dental clinic G.Vogel, San Paolo hospital,Milan.
Pre-assignment Details  
Arm/Group Title Test Group Control Group
Hide Arm/Group Description

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.

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).

Period Title: Overall Study
Started 21 21
Completed 21 21
Not Completed 0 0
Arm/Group Title Test Group Control Group Total
Hide Arm/Group Description

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.

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).

Total of all reporting groups
Overall Number of Baseline Participants 21 21 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
 100.0%
21
 100.0%
42
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 21 participants 42 participants
35.4  (6) 38.4  (5) 36.9  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 21 participants 42 participants
Female
9
  42.9%
15
  71.4%
24
  57.1%
Male
12
  57.1%
6
  28.6%
18
  42.9%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Italy Number Analyzed 21 participants 21 participants 42 participants
21
 100.0%
21
 100.0%
42
 100.0%
1.Primary Outcome
Title Post-operative Pain: VAS
Hide Description 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.
Time Frame 2 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
20.00
(12 to 29)
62
(33 to 80)
2.Primary Outcome
Title Post-operative Discomfort
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
39
(21 to 40)
60
(59 to 80)
3.Primary Outcome
Title Post-operative Stress
Hide Description 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.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
21
(10 to 49.9)
50
(29 to 62)
4.Primary Outcome
Title Post-operative Inability to Chew
Hide Description

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.

Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Test Group Control Group
Hide Arm/Group Description:

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.

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).

Overall Number of Participants Analyzed 21 21
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
60
(39 to 70)
60
(59 to 80)
Time Frame 90 days after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Test Group Control Group
Hide Arm/Group Description

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.

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).

All-Cause Mortality
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Test Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Fulvio Gatti
Organization: Azienda Ospedaliera San Paolo - Università degli Studi di Milano
Phone: 3396441920
EMail: fudy@libero.it
Layout table for additonal information
Responsible Party: Eliam Scaramuzza, Azienda Ospedaliera San Paolo
ClinicalTrials.gov Identifier: NCT03685396     History of Changes
Other Study ID Numbers: PRF
First Submitted: September 24, 2018
First Posted: September 26, 2018
Results First Submitted: September 26, 2018
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019