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

NCT03685396 | Completed Results

• 1 other identifier: PRF
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Postoperative Complications; Gingival Recession

Keywords

Connective tissue graft; Platelet concentrates; PRF; Mucogingival surgery

Outcome Measures

Primary Outcomes (4)

• 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.

• 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

• 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

• 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

Study Arms (2)

Test Group

EXPERIMENTAL

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.

Biological: Platelet rich fibrin ( PRF)

Control Group

ACTIVE COMPARATOR

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

Drug: hemostatic agents with oxidized and regenerated cellulosa

Interventions

Platelet rich fibrin ( PRF) BIOLOGICAL

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.

Test Group

hemostatic agents with oxidized and regenerated cellulosa DRUG

In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0).

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliera San Paolo: lead

Study Sites (1)

Azienda Ospedaliera San Paolo - Polo Universitario - Università degli Studi di Milano

Milan, Milano, 20142, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Complications; Gingival Recession

Interventions

Hemostasis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Results Point of Contact

• Title: Dr.Fulvio Gatti
• Organization: Azienda Ospedaliera San Paolo - Università degli Studi di Milano

fudy@libero.it

3396441920

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 26, 2018
• Study Start: November 27, 2017
• Primary Completion: July 23, 2018
• Study Completion: September 9, 2018
• Last Updated: August 5, 2019
• Results First Posted: August 5, 2019

Record last verified: 2019-06

Locations

IT (1)