Evaluation of Platelets Rich Fibrin and Nanohydroxyapatite in the Treatment of Intrabony Defects

Study Overview
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Brief Summary
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Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. Researches had demonstrated the benefits of platelet concentrates bine grafts in osseous regeneration in the areas of periodontal surgery. Aim of the study: to evaluate the effect of PRF with/without nanohydroxyapatite in periodontal intrabony defects.

Detailed Description
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Background: the ultimate goal of periodontal therapy is the regeneration of periodontal tissues. The regenerative and wound healing potential of platelets has attracted much attention over the last few years. Researches had demonstrated the benefits of platelet concentrates in osseous regeneration in the areas of periodontal surgery and implantology. In addition, nanohydroxyapatite was shown to be unsheathed by newly formed bone and partly replaced by it, but resorbed very slowly, as shown in animal experiments after 9 months or in clinical studies after a 6-month observation period. The clinical and biochemical studies evaluating the regenerative effect of PRF alone or in combination with nanohydroxyapatite in periodontal intrabony defects are still deficient. Aim of the study: to evaluate clinical and biochemical effect of PRF with/without nanohydroxyapatite in treatment of human intrabony defects.

Official Title
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Clinical and Biochemical Evaluation of Platelets Rich Fibrin (PRF) and Nanohydroxyapatite in the Treatment of Intrabony Defects

Conditions
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Bony Defects

Intervention / Treatment
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* Procedure: OFD alone
* Drug: Platelet rich Fibrin
* Drug: Nanohydroxyapatite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients are free from systemic illness. All patients should be diagnosed as having chronic periodontitis. Patients should be cooperative, motivated and willing to follow our treatment protocol and follow up visits. Patients selected had not received antibiotics or anti-inflammatory therapy in the 6 months prior to examination. Exclusion Criteria: Presence of areas of periodontal pocket of (probing depth ≥5 and clinical attachment level (CAL) ≥ 3). Patients who have received any type of periodontal treatment in the past 6 months prior to examination.

Ages Eligible for Study
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Minimum Age: 20 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: OFD alone<br>Control group: including 15 defects that will receive open flap debridement (OFD). | Procedure: OFD alone<br>* Periodontal surgical cleaning procedure<br>* Other names: Periodontal Surgery;|
| Active Comparator: PRF + OFD<br>Test group (1): including 15 defects that will receive platelet rich fibrin (PRF) with open flap debridement (OFD). | Procedure: OFD alone<br>* Periodontal surgical cleaning procedure<br>* Other names: Periodontal Surgery;Drug: Platelet rich Fibrin<br>* Natural platelet concentrate rich in growth factors<br>* Other names: Natural growth factor;|
| Active Comparator: Bone + OFD<br>Test group (2): including 15 defects that will receive nanohydroxyapatite bone graft with open flap debridement OFD). | Procedure: OFD alone<br>* Periodontal surgical cleaning procedure<br>* Other names: Periodontal Surgery;Drug: Nanohydroxyapatite<br>* Synthetic bone graft<br>* Other names: Bone graft;|
| Active Comparator: PRF + Bone + OFD<br>Test group (3): including 15 defects that will receive nanohydroxyapatite bone graft with platelet rich fibrin (PRF) after open flap debridement (OFD). | Procedure: OFD alone<br>* Periodontal surgical cleaning procedure<br>* Other names: Periodontal Surgery;Drug: Platelet rich Fibrin<br>* Natural platelet concentrate rich in growth factors<br>* Other names: Natural growth factor;Drug: Nanohydroxyapatite<br>* Synthetic bone graft<br>* Other names: Bone graft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gingival crevicular fluid (GCF) | GCF will be collected after removing saliva and supra-gingival plaque using methylcellulose filter paper strip that will be inserted in the periodontal pocket and will be let in for 30 seconds. | up to 3 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Gingival index | Gingival index (GI) developed on 1963. | up to 3 months | 
| Changes in level of attachment loss | Attachment loss: will be measured from the cemento-enamel junction (CEJ) to the apical part of the sulcus. | up to 3 months | 
| Changes in probing pocket depth | Probing pocket depth (PD): six measurements per tooth will be recorded by using the University of Michigan O periodontal probe with Williams markings. | up to 3 months |