Platelet Rich Fibrin in Soft Tissue Healing After Implant Uncovering

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healing Surgical Wounds

Intervention / Treatment
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* Procedure: Application of L-PRF on the donor area
* Procedure: Secondary intention healing of the donor area


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APF + L-PRF<br>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<br>* After implant uncovering procedure with apically positioned flap, the donor area is covered with a layer of L-PRF<br>|
| Active Comparator: APF without L-PRF<br>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<br>* After implant uncovering procedure with apically positioned flap, the donor area is left to heal by secondary intention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Consumption of Analgesics (AU) | Assessment of postoperative pain by the number of analgesics taken | 4 weeks | 
| Alteration of Sensivity (AS) | Evaluation of alteration of sensivity on donor area | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Platelet Rich Fibrin, Wound Healing, Implant Uncovering