Trial Outcomes & Findings for Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage (NCT NCT03685396)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

2 weeks.

Results posted on

2019-08-05

Participant Flow

42 subjects were selected from those seeking care at the Department of oral surgery, Dental clinic G.Vogel, San Paolo hospital,Milan.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	21	21
Overall Study COMPLETED	21	21
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Group n=21 Participants 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 n=21 Participants 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 n=42 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=21 Participants	21 Participants n=21 Participants	42 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=21 Participants	0 Participants n=21 Participants	0 Participants n=42 Participants
Age, Continuous	35.4 years STANDARD_DEVIATION 6 • n=21 Participants	38.4 years STANDARD_DEVIATION 5 • n=21 Participants	36.9 years STANDARD_DEVIATION 5.5 • n=42 Participants
Sex: Female, Male Female	9 Participants n=21 Participants	15 Participants n=21 Participants	24 Participants n=42 Participants
Sex: Female, Male Male	12 Participants n=21 Participants	6 Participants n=21 Participants	18 Participants n=42 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Italy	21 Participants n=21 Participants	21 Participants n=21 Participants	42 Participants n=42 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Group n=21 Participants 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 n=21 Participants 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).
Post-operative Pain: VAS	20.00 score on a scale Interval 12.0 to 29.0	62 score on a scale Interval 33.0 to 80.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Group n=21 Participants 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 n=21 Participants 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).
Post-operative Discomfort	39 score on a scale Interval 21.0 to 40.0	60 score on a scale Interval 59.0 to 80.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Group n=21 Participants 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 n=21 Participants 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).
Post-operative Stress	21 score on a scale Interval 10.0 to 49.9	50 score on a scale Interval 29.0 to 62.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Test Group n=21 Participants 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 n=21 Participants 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).
Post-operative Inability to Chew	60 score on a scale Interval 39.0 to 70.0	60 score on a scale Interval 59.0 to 80.0

Adverse Events

Test Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Fulvio Gatti

Azienda Ospedaliera San Paolo - Università degli Studi di Milano

Phone: 3396441920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place