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Platelet Rich Fibrin in the Treatment of Palatal Wounds

Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02438046
Enrollment
40
Registered
2015-05-08
Start date
2015-05-31
Completion date
2015-06-30
Last updated
2015-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gingival Recession

Keywords

Connective Tissue Grafts, Wound healing, Biomaterials, Pain, Clinical Trials, Mucogingival Surgery

Brief summary

In this study it will be investigated the usefulness of Platelet-Rich Fibrin (PRF) on in the epithelialized connective tissue graft palatal donor site healing acceleration and in the patient's morbidity reduction. Forty 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 group 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.

Interventions

PROCEDUREPalatal wound bandage

Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.

Sponsors

G. d'Annunzio University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
Yes

Inclusion criteria

are as follows: * 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

Design outcomes

Primary

MeasureTime frame
The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal woundfour weeks

Countries

Italy

Contacts

Primary ContactMichele Paolantonio, MD; DDS
mpaoantonio@unich.it+393395204073

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026