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Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

Primary Purpose

Healing Surgical Wounds

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Application of L-PRF on the donor area
Secondary intention healing of the donor area
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healing Surgical Wounds focused on measuring Platelet Rich Fibrin, Wound Healing, Implant Uncovering

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • G. D'Annunzio University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APF + L-PRF

APF without L-PRF

Arm Description

Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF).

The donor area is left to heal by secondary intention after APF in the implant uncovering procedure.

Outcomes

Primary Outcome Measures

Complete re-epithelialization of the wound of donor area (CWE)
Time needed to obtain a complete re-epithelialization of the wound of donor area

Secondary Outcome Measures

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).
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).
Consumption of Analgesics (AU)
Assessment of postoperative pain by the number of analgesics taken
Alteration of Sensivity (AS)
Evaluation of alteration of sensivity on donor area

Full Information

First Posted
May 10, 2022
Last Updated
December 15, 2022
Sponsor
G. d'Annunzio University
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1. Study Identification

Unique Protocol Identification Number
NCT05375357
Brief Title
Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 20, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healing Surgical Wounds
Keywords
Platelet Rich Fibrin, Wound Healing, Implant Uncovering

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APF + L-PRF
Arm Type
Experimental
Arm Description
Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF).
Arm Title
APF without L-PRF
Arm Type
Active Comparator
Arm Description
The donor area is left to heal by secondary intention after APF in the implant uncovering procedure.
Intervention Type
Procedure
Intervention Name(s)
Application of L-PRF on the donor area
Intervention Description
After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF
Intervention Type
Procedure
Intervention Name(s)
Secondary intention healing of the donor area
Intervention Description
After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention
Primary Outcome Measure Information:
Title
Complete re-epithelialization of the wound of donor area (CWE)
Description
Time needed to obtain a complete re-epithelialization of the wound of donor area
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Post-Operative Discomfort (D)
Description
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).
Time Frame
4 weeks
Title
Changes in Feedind Habits (CFH)
Description
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).
Time Frame
4 weeks
Title
Consumption of Analgesics (AU)
Description
Assessment of postoperative pain by the number of analgesics taken
Time Frame
4 weeks
Title
Alteration of Sensivity (AS)
Description
Evaluation of alteration of sensivity on donor area
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
G. D'Annunzio University
City
Chieti
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

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