Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

Healing Surgical Wounds Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05375357
• Other study ID #: 19102021
• Status: Completed
• Phase: N/A
• Start date: April 20, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: May 2022
• Source: G. d'Annunzio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healing Surgical Wounds
• Surgical Wound

Intervention

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
• 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

Locations

Country	Name	City	State
Italy	G. D'Annunzio University	Chieti

Sponsors (1)

Lead Sponsor	Collaborator
G. d'Annunzio University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Consumption of Analgesics (AU)	Assessment of postoperative pain by the number of analgesics taken	4 weeks
Secondary	Alteration of Sensivity (AS)	Evaluation of alteration of sensivity on donor area	4 weeks