Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

Evaluation of Healing Time and Postoperative Morbidity After Implant Uncovering With Vestibularly Repositioned Flap Associated With Leucocyte Platelet Rich Fibrin (L-PRF): a Randomized and Controlled Clinical Trial

This study represents a prospective, controlled and randomized clinical trial assessing the effects of L-PRF on the healing time of the donor area and on the patient's postoperative morbidity in the 4 weeks following the Apically Positioned Flap (APF) procedure in the uncovering phase of two-stage implants.

A total of 40 patients were recruited and divided into two groups. The implant uncovering procedure in the test group was performed with APF and application of L-PRF on the donor area. Patients in the control group, on the other hand, were treated with APF alone, leaving the donor area to heal by secondary intention.

Study Overview

• Status: Completed
• Conditions: Healing Surgical Wounds
• Intervention / Treatment: Procedure: Application of L-PRF on the donor area; Procedure: Secondary intention healing of the donor area

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • G. d'Annunzio University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• to have at least one implant in the maxilla with a quantity of vestibular keratinized gingiva < 2 mm
• to be in good systemic health
• to have a good oral hygiene (FMPS and FMBS < 20%)

Exclusion Criteria:

• systemic diseases: coagulation disorders; medications affecting periodontal status in the previous 6 months; pregnancy or lactation;
• smoking habits;
• peri-implant surgery on the experimental sites.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: APF + L-PRF; Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF).	Procedure: Application of L-PRF on the donor area; After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF
Active Comparator: APF without L-PRF; The donor area is left to heal by secondary intention after APF in the implant uncovering procedure.	Procedure: Secondary intention healing of the donor area; After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete re-epithelialization of the wound of donor area (CWE)	Time needed to obtain a complete re-epithelialization of the wound of donor area	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Operative Discomfort (D)	Evaluation of post-operative discomfort using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).	4 weeks
Changes in Feedind Habits (CFH)	Evaluation of changes in patients' feedind habits using Visual Analogue Scale (VAS).The scale is represented by a straight horizontal line of fixed length, generally 10 cm. Extremities are defined as extreme limits of the parameter to be measured, oriented from left (worst) to right (best).	4 weeks
Consumption of Analgesics (AU)	Assessment of postoperative pain by the number of analgesics taken	4 weeks
Alteration of Sensivity (AS)	Evaluation of alteration of sensivity on donor area	4 weeks

Collaborators and Investigators

• Sponsor: G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: May 10, 2022
• First Submitted That Met QC Criteria: May 10, 2022
• First Posted (Actual): May 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 19, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Wound Healing; Platelet Rich Fibrin; Implant Uncovering
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: 19102021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No