Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in Management of Periodontal Intrabony Defects

Study Overview
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Brief Summary
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A clinical and radiographic evaluation of Nano-crystalline hydroxyapatite silica gel in comparison with open flap debridement for management of periodontal intrabony defects.

Detailed Description
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Thirty patients suffering from advanced chronic periodontitis were included in this randomized controlled clinical trial. Each subject contributed matched two- or three-walled intrabony defects. Patients were equally assigned into the experimental group; Nano-crystalline hydroxyapatite silica gel or the negative control group;open flap debridement. Clinical and radiographic parameters were recorded at baseline and at 3 and 6 months postoperatively.

Official Title
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Clinical and Radiographic Evaluation of Nano-crystalline Hydroxyapatite Silica Gel in the Treatment of Human Periodontal Intrabony Defects

Conditions
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Chronic Periodontitis

Intervention / Treatment
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* Biological: Nano-crystalline hydroxyapatite silica gel
* Procedure: open flap debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe chronic periodontitis patients. having at least one site with pocket depth ≥ 6 mm and clinical attachment level ≥ 5 mm, with radiographic evidence of bone loss as detected in periapical radiographs. Exclusion Criteria: Pregnant women Subjects had <22 permanent teeth Having any given systemic disease Taking any type of medication and/or antibiotic therapy during the 3 months before the study Received periodontal treatment within the past 12 months Current or former smokers

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nano-crystalline hydroxyapatite silica gel<br>hydroxyapaptite bone graft with nano particle size in silica gel will be used to fill in the defect after opening a periodontal flap | Biological: Nano-crystalline hydroxyapatite silica gel<br>* it is a type of synthetic bone graft.<br>* Other names: Nanobone;|
| Sham Comparator: Open flap debridement<br>an open periodontal flap without adding bone graft. | Procedure: open flap debridement<br>* a periodontal surgical procedure for the purpose of debridement.<br>* Other names: OFD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level | Change from baseline in clinical attachment level in mm in chronic periodontitis patients at 6 month | change from Baseline at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pocket depth | Estimation of pocket depth in mm in chronic periodontitis patients at baseline and 6 months | Baseline and 6 months | 
| bone defect area | Estimation of bone fill defect area in mm square in chronic periodontitis patients at baseline and 6 month | Baseline and 6 months |