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Completed

NCT Number: NCT04043039

Platelet Rich Fibrin in the Treatment of Full Thickness Palatal Wounds

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

G. d'Annunzio University

Chieti, CH, 66100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Palatal wound bandage with PRF

Procedure

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

Procedure

palatal wound will be protected by gelatine sponge

Primary outcomes

  1. Time needed to obtain a complete re epithelialization of the palatal wound

    Time frame: 4 weeks

    The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2019
Registry last updated
Mar 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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