Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

Not Applicable

Completed

• Conditions: Healing Surgical Wounds
• Interventions: Procedure: Secondary intention healing of the donor area; Procedure: Application of L-PRF on the donor area

• Registration Number: NCT05375357
• Lead Sponsor: G. d'Annunzio University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-10
• Study First Submitted QC: 2022-05-10
• Study First Posted: 2022-05-16
• Primary Completion: 2022-07-30
• Study Completion: 2022-07-30
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APF without L-PRF	Secondary intention healing of the donor area	The donor area is left to heal by secondary intention after APF in the implant uncovering procedure.
APF + L-PRF	Application of L-PRF on the donor area	Application of a layer of L-PRF to protect the donor area after uncovering implant procedure using Apically Positioned Flap (APF).

Primary Outcome Measures

Name	Time	Method
Complete re-epithelialization of the wound of donor area (CWE)	4 weeks	Time needed to obtain a complete re-epithelialization of the wound of donor area

Secondary Outcome Measures

Name	Time	Method
Post-Operative Discomfort (D)	4 weeks	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)	4 weeks	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)	4 weeks	Assessment of postoperative pain by the number of analgesics taken
Alteration of Sensivity (AS)	4 weeks	Evaluation of alteration of sensivity on donor area

Trial Locations

Locations (1)

G. D'Annunzio University; 🇮🇹 Chieti, Italy