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Platelet Rich Fibrin in the Treatment of Palatal Wounds

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ClinicalTrials.gov Identifier: NCT02438046
Recruitment Status : Unknown
Verified May 2015 by Michele Paolantonio, G. d'Annunzio University.
Recruitment status was:  Not yet recruiting
First Posted : May 8, 2015
Last Update Posted : May 8, 2015
Sponsor:
Information provided by (Responsible Party):
Michele Paolantonio, G. d'Annunzio University

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.

Condition or disease Intervention/treatment Phase
Gingival Recession Procedure: Palatal wound bandage Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Platelet Rich Fibrin in the Treatment of Palatal Wounds After Epithelialized Free Gingival Grafts Harvesting. A Randomized Clinical Trial
Study Start Date : May 2015
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Palatal wound bandage by PRF
Intervention: In the test group (n=20 patients) the palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes
Procedure: Palatal wound bandage
Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.

Placebo Comparator: Palatal wound bandage by gelatin sponge
Intervention: The control group patients (n=20) will have their palatal wound medicated by absorbable gelatin sponge.
Procedure: Palatal wound bandage
Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.




Primary Outcome Measures :
  1. The primary outcome is to assess the time needed to obtain a complete re epithelialization of the palatal wound [ Time Frame: four weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438046


Contacts
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Contact: Michele Paolantonio, MD; DDS +393395204073 mpaoantonio@unich.it

Locations
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Italy
G. d'Annunzio University
Chieti, CH, Italy, 66100
Contact: Michele Paolantonio, MD; DDS    +393395204073    mpaolantonio@unich.it   
Sponsors and Collaborators
G. d'Annunzio University
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Responsible Party: Michele Paolantonio, Full time professor, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT02438046    
Other Study ID Numbers: 1/2015
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: May 8, 2015
Last Verified: May 2015
Keywords provided by Michele Paolantonio, G. d'Annunzio University:
Connective Tissue Grafts
Wound healing
Biomaterials
Pain
Clinical Trials
Mucogingival Surgery
Additional relevant MeSH terms:
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Gingival Recession
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Periodontal Atrophy