Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

Gingival Recession Clinical Trial

Official title:

Platelet Rich Fibrin in the Treatment of Palatal Wounds After Full Thickness Palatal Grafts Harvesting: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043039
• Other study ID #: 072019
• Status: Completed
• Phase: N/A
• Start date: September 2, 2019
• Est. completion date: November 4, 2019

Study information

• Verified date: March 2023
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the full thickness palatal graft donor site healing acceleration and in the patient's morbidity reduction. Eighty patients, with at least one gingival recession will be treated by a flap with connective tissue graft(CTG). In the test group (20 patients) and in the control group 2 a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups 2-4 patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.

Description:

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the full thickness palatal graft donor site healing acceleration and in the patient's morbidity reduction. Eighty patients, with at least one gingival recession will be treated by a coronally advanced flap (CAF) with connective tissue graft(CTG) resulting from the de-epithelialization of a free gingival graft. In the test group (20 patients) a quadruple layer of PRF membrane will be placed over the palatal wounds; conversely, the control groups patients will be treated by an absorbable gelatin sponge. Patients will be monitored at 1, 2, 3 and 4 weeks after surgery for the complete re-epithelialization of the palatal wound (CWE), the alteration of sensibility (AS) around the wound area, the post-operative discomfort (D), and the changes of feeding habits (CFH) by a visual analogic scale (VAS) evaluation. Furthermore, the analgesics consumption and the existence of delayed bleeding from the palatal wound (DWB) during the first post-operative week will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 4, 2019
• Est. primary completion date: October 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• to have a single gingival recession to be treated by a mucogingival surgery intervention

• to be in good systemic health

• to have a good oral hygiene

Exclusion Criteria:

• no systemic diseases; no coagulation disorders; no medications affecting periodontal status in the previous 6 months; no pregnancy or lactation;

• no smoking habits;

• no periodontal surgery on the experimental sites;

• no inadequate endodontic treatment

• no tooth mobility at the site of surgery

Related Conditions & MeSH terms

• Gingival Recession

Intervention

Procedure:
• Palatal wound bandage with PRF
palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes
• Palatal wound bandage with Gelatine Sponge
palatal wound will be protected by gelatine sponge

Locations

Country	Name	City	State
Italy	G. d'Annunzio University	Chieti	CH

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time needed to obtain a complete re epithelialization of the palatal wound	The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound	4 weeks