Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

NCT05375357 | Completed

• 1 other identifier: 19102021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healing Surgical Wounds

Keywords

Platelet Rich Fibrin; Wound Healing; Implant Uncovering

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Post-Operative Discomfort (D)

  4 weeks

• Changes in Feedind Habits (CFH)

  4 weeks

• Consumption of Analgesics (AU)

  4 weeks

• Alteration of Sensivity (AS)

  4 weeks

Study Arms (2)

APF + L-PRF

EXPERIMENTAL

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

APF without L-PRF

ACTIVE COMPARATOR

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

Interventions

Application of L-PRF on the donor area PROCEDURE

After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF

APF + L-PRF

Secondary intention healing of the donor area PROCEDURE

After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention

APF without L-PRF

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%)

You may not qualify if:

• 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.

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

G. D'Annunzio University

Chieti, 66100, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time professor

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 16, 2022
• Study Start: April 20, 2021
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)