PLATELET RICH FIBRIN COMBINED WITH 1.2% ATORVASTATIN FOR TREATMENT OF INTRABONY DEFECTS IN CHRONIC PERIODONTITIS

Study Overview
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Brief Summary
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Current study was designed to evaluate the combined efficacy of PRF and 1.2% ATV gel with open flap debridement (OFD) in treatment of intrabony defects in chronic periodontitis subjects.

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: Platelet rich fibrin +Atorvastatin
* Drug: Platelet rich fibrin
* Procedure: open flap debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: the presence of 3- wall IBD ≥3 mm deep (distance between alveolar crest and base of the defect on an intraoral periapical radiograph [IOPA]) along with an interproximal probing depth (PD) ≥5 mm after phase I therapy (scaling and root planing [SRP]) in asymptomatic teeth. Exclusion Criteria: 1) Agressive Periodontitis subjects; 2) Systemic conditions known to affect the periodontal status; 3) medications known to affect the outcomes of periodontal therapy; 4) Hematological disorders and insufficient platelet count (<200,000/mm3); 5) pregnancy/lactation; and 6) Smoking and tobacco use in any form 7) Immunocompromised individuals.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Platelet rich fibrin + atorvastatin<br>In Platelet rich fibrin+ATV group PRF combined with 10 µl of 1.2% ATV was inserted into the depth of the IBD | Drug: Platelet rich fibrin +Atorvastatin<br> <br> |
| Sham Comparator: Platelet rich fibrin<br>In Platelet rich fibrin group PRF was inserted into the depth of the IBD. | Drug: Platelet rich fibrin<br> <br> |
| Other: Open flap debridement<br>open flap debridement was followed by no grafting or regenerative intervention. | Procedure: open flap debridement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage radiographic defect depth reduction | Defect depth reduction will be assessed from baseline to 9 month post operatively on radiographs | 9 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in probing depth | probing depth will be assessed from gingival margin to pocket depth at baseline and 9 months postoperatively | 9 months from baseline | 
| change in relative attachment level | RAL will be assesed from fixed point on the stent at baseline and 9 months postoperatively | 9 months from baseline | 
| change in plaque levels | plaque levels were assessed at baseline and 9 months postoperatively | 9 months from baseline | 
| change in gingival bleeding | gingival bleeding was assesed at baseline and 9 months postoperatively | 9 months from baseline | 
| change in gingival margin levels | change in gingival margin levels were assesed at baseline and 9 months | 9 months from baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontitis, Surgery, Growth Factors, Statins