Gingival Recession, Postoperative Complications, Postoperative Pain
Conditions
Keywords
Connective tissue graft, Platelet concentrates, PRF, Mucogingival surgery
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.
Interventions
BIOLOGICALPlatelet 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.
DRUGhemostatic 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).
Sponsors
Azienda Ospedaliera San Paolo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain: VAS | 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. |
| Post-operative Discomfort | 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. |
| Post-operative Stress | 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. |
| Post-operative Inability to Chew | 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. |
Countries
Italy
Participant flow
Recruitment details
42 subjects were selected from those seeking care at the Department of oral surgery, Dental clinic G.Vogel, San Paolo hospital,Milan.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| 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). | 21 |
| Total | 42 |
Baseline characteristics
| Characteristic | Control Group | Total | Test Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 42 Participants | 21 Participants |
| Age, Continuous | 38.4 years STANDARD_DEVIATION 5 | 36.9 years STANDARD_DEVIATION 5.5 | 35.4 years STANDARD_DEVIATION 6 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Italy | 21 Participants | 42 Participants | 21 Participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 9 Participants |
| Sex: Female, Male Male | 6 Participants | 18 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 21 |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Post-operative Discomfort | 39 score on a scale |
| Control Group | Post-operative Discomfort | 60 score on a scale |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Post-operative Inability to Chew | 60 score on a scale |
| Control Group | Post-operative Inability to Chew | 60 score on a scale |
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.
Time frame: 2 weeks.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Post-operative Pain: VAS | 20.00 score on a scale |
| Control Group | Post-operative Pain: VAS | 62 score on a scale |
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.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Test Group | Post-operative Stress | 21 score on a scale |
| Control Group | Post-operative Stress | 50 score on a scale |