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

Primary Purpose

Postoperative Pain, Postoperative Complications, Gingival Recession

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Platelet rich fibrin ( PRF)
hemostatic agents with oxidized and regenerated cellulosa
Sponsored by
Azienda Ospedaliera San Paolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Connective tissue graft, Platelet concentrates, PRF, Mucogingival surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 (β‰₯ 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.

Sites / Locations

  • Azienda Ospedaliera San Paolo - Polo Universitario - UniversitΓ  degli Studi di Milano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test Group

Control Group

Arm 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.

In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 24, 2018
Last Updated
June 14, 2019
Sponsor
Azienda Ospedaliera San Paolo
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1. Study Identification

Unique Protocol Identification Number
NCT03685396
Brief Title
Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage
Official Title
Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage: a Comparative Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
July 23, 2018 (Actual)
Study Completion Date
September 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Azienda Ospedaliera San Paolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Postoperative Complications, Gingival Recession
Keywords
Connective tissue graft, Platelet concentrates, PRF, Mucogingival surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Group
Arm Type
Experimental
Arm 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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin ( PRF)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
hemostatic agents with oxidized and regenerated cellulosa
Intervention Description
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 Measure Information:
Title
Post-operative Pain: VAS
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.
Title
Post-operative Discomfort
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
Title
Post-operative Stress
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
Title
Post-operative Inability to Chew
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 (β‰₯ 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.
Facility Information:
Facility Name
Azienda Ospedaliera San Paolo - Polo Universitario - UniversitΓ  degli Studi di Milano
City
Milan
State/Province
Milano
ZIP/Postal Code
20142
Country
Italy

12. IPD Sharing Statement

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

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