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

Postoperative Pain Clinical Trial

Official title:

Patient Morbidity After Palatal Free Gingival Grafts With or Without PRF Membranes Coverage: a Comparative Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03685396
• Other study ID #: PRF
• Status: Completed
• Phase: N/A
• Start date: November 27, 2017
• Est. completion date: September 9, 2018

Study information

• Verified date: June 2019
• Source: Azienda Ospedaliera San Paolo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 9, 2018
• Est. primary completion date: July 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Recession
• Pain, Postoperative
• Postoperative Complications
• Postoperative Pain

Intervention

Biological:
• 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.

Drug:
• 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).

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano	Milan	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Paolo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	2 weeks.
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.	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.	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.	2 weeks