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

Not Applicable

Completed

• Conditions: Postoperative Pain; Gingival Recession; Postoperative Complications
• Interventions: Drug: hemostatic agents with oxidized and regenerated cellulosa; Biological: Platelet rich fibrin ( PRF)

• Registration Number: NCT03685396
• Lead Sponsor: Azienda Ospedaliera San Paolo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-27
• Primary Completion: 2018-07-23
• Study Completion: 2018-09-09
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-25
• Study First Posted: 2018-09-26
• Results First Submitted: 2018-09-26
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-14
• Last Update Submitted: 2019-06-14
• Results First Posted: 2019-08-05
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	hemostatic agents with oxidized and regenerated cellulosa	In Control Group hemostatic agents with oxidized and regenerated cellulosa were used to cover the donor site.
Test Group	Platelet rich fibrin ( PRF)	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.

Primary Outcome Measures

Name	Time	Method
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 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 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 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.

Trial Locations

Locations (1)

Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano; 🇮🇹 Milan, Milano, Italy