Evaluation of Adjunctive Injectable PRF Therapy Used in Conjunction With Scaling and Root Planning

Study Overview
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Brief Summary
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Clinical evaluation of local administration of injectable PRF (injectable platelet-rich fibrin) in periodontal pockets as adjunctive therapy to scaling and root planing. 15 periodontal patients will receive a through traditional mechanical treatment (scaling and root planing). Each patient will receive subgingival i-PRF injected in half mouth and the opposite side will be injected with saline, immediately after the deep scaling session.

Detailed Description
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The aim of the study is to evaluate the efficacy of i-PRF subgingival injection right after scaling and root planing as adjunctive therapy to traditional mechanical therapy. 15 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. I-PRF will be applied subgingivally in the deep pockets in a half mouth design. The injected half mouth (study group) for each patient will be allocated randomly. The opposite side will be injected with saline (control group). Clinical parameters will be evaluated: plaque index (PI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL). Clinical measurements will be performed at baseline and at 8 weeks.

Official Title
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Clinical Effectiveness of a Topical Subgingival Application of Injectable Platelet-rich Fibrin as Adjunctive Therapy to Scaling and Root Planing. A Double-blind Split Mouth Randomized Prospective Comparative Controlled Trial

Conditions
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Periodontal Pockets

Intervention / Treatment
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* Procedure: : i-PRF
* Procedure: saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are in general good health. Patients are from both gender and are adult. A sign informed consent from participation and permission to use obtained data for research purposes. They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months. Presence of bilateral periodontal pockets (≥5 mm) on the minimum of 2 teeth in each side. Exclusion Criteria: Patients less than 18 years' old Immunosuppressive systemic diseases (like cancer, AIDS, diabetes…) clotting and Hematological disorders Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use The teeth with poor bad filling and poorly fitted restorations

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: i-PRF (Test)<br>injected subgingivally i-PRF after scaling and root planing | Procedure: : i-PRF<br>* The description of this intervention has been already given before<br>|
| Active Comparator: saline (Control)<br>injected subgingivally saline after scaling and root planing | Procedure: saline<br>* The description of this intervention has been already given before<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level (CAL) | measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 University of North Carolina) | baseline, 2 months | 
| Probing pocket depth (PD) | measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 University of North Carolina) | baseline, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| full mouth Plaque Index Quigely Hein Index (modified by Turesky et al, 1970) | 0 No plaque Separate flecks of plaque at the cervical margin of the tooth A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth A band of plaque wider than one mm but covering less than one-third of the crown of the tooth Plaque covering at least one-third but less than two-thirds of the crown of the tooth Plaque covering two-thirds or more of the crown of the tooth labial/ buccal and lingual surfaces are assessed after using disclosing solution. An index for the entire mouth is determined by dividing the total score by the number surfaces examined. | baseline, 2 months | 
| Modified Gingival Index (Trombelli et al. 2004) | 0 = Normal gingiva; = Mild inflammation - slight change in color and slight edema; = Moderate inflammation - redness, edema and glazing; = Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding. will be evaluated visually | baseline, 2 months | 
| Bleeding on probing (BOP) | All six sites of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage. - no bleeding upon probing (not recorded) + bleeding upon probing Calculation: BOP= Number of bleeding sites x100/ Number of sites evaluated will be evaluated visually and used a UNC-15 mm University of North Carolina periodontal probe | baseline, 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal pockets, injectable platelet-rich fibrin, saline