NCT04043039

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 4, 2019

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

1 month

First QC Date

July 30, 2019

Last Update Submit

March 14, 2023

Conditions

Gingival Recession

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

FULL THICKNESS PALATAL GRAFT

EXPERIMENTAL

the full thickness palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membrane or by gelatine sponge

Procedure: Palatal wound bandage with PRFProcedure: Palatal wound bandage with Gelatine Sponge

FREE GINGIVAL GRAFT

ACTIVE COMPARATOR

the Epithelialized Free Gingival Grafts palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membrane or by gelatine sponge

Procedure: Palatal wound bandage with PRFProcedure: Palatal wound bandage with Gelatine Sponge

Interventions

Palatal wound bandage with PRFPROCEDURE

palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes

FREE GINGIVAL GRAFTFULL THICKNESS PALATAL GRAFT
Palatal wound bandage with Gelatine SpongePROCEDURE

palatal wound will be protected by gelatine sponge

FREE GINGIVAL GRAFTFULL THICKNESS PALATAL GRAFT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G. d'Annunzio University

Chieti, CH, 66100, Italy

Location

MeSH Terms

Conditions

Gingival Recession

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Study Officials

  • michele paolantonio

    università G. D'annunzio Chieti-Pescara

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Periodontology

Study Record Dates

First Submitted

July 30, 2019

First Posted

August 2, 2019

Study Start

September 2, 2019

Primary Completion

October 2, 2019

Study Completion

November 4, 2019

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)