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Clinical Trials/NCT05375357
NCT05375357
Completed
Not Applicable

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

G. d'Annunzio University1 site in 1 country40 target enrollmentApril 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healing Surgical Wounds
Sponsor
G. d'Annunzio University
Enrollment
40
Locations
1
Primary Endpoint
Complete re-epithelialization of the wound of donor area (CWE)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2021
End Date
July 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
G. d'Annunzio University
Responsible Party
Principal Investigator
Principal Investigator

Michele Paolantonio

Full time professor

G. d'Annunzio University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Complete re-epithelialization of the wound of donor area (CWE)

Time Frame: 4 weeks

Time needed to obtain a complete re-epithelialization of the wound of donor area

Secondary Outcomes

  • 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 Sites (1)

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