Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

Study Overview
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Brief Summary
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Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid. 120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

Detailed Description
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The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

Official Title
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Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial

Conditions
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CHRONIC PERIODONTITIS

Intervention / Treatment
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* Other: Placebo gel
* Drug: Hyaluronic acid gel
* Biological: Platelet rich fibrin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are in general good health. Patients having minimum of 20 permanent teeth. They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months. Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm. Exclusion Criteria: Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.) Clotting and Hematological disorders Patients with grade III mobility. Patients with smoking and alcohol consuming habit. Pregnant and lactating female. Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use) The teeth with poor filling and ill fitted restorations

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Negative control<br>Placebo gel | Other: Placebo gel<br>* Localized subgingival application<br>* Other names: Cellulose gel;|
| Experimental: Test group 1<br>Hyaluronic acid gel | Drug: Hyaluronic acid gel<br>* Localized subgingival application<br>|
| Experimental: Test group 2<br>injectable prf | Biological: Platelet rich fibrin<br>* Localized subgingival application<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) | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth | 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) | 3 Months |