Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects

Study Overview
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Brief Summary
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The aim of this study will be to evaluate, clinically, and radiographically the effect of Nigella Sativa oil extract Mixed with xenograft versus xenograft alone in the treatment of intra-bony defects in patients with aggressive periodontitis.

Detailed Description
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in 10 patients, twenty sites in subjects with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone. At baseline, 3, 6 after surgery, the following clinical parameters (PD, CAL, BOP) and CBCT at baseline and 6 months x-ray will be recorded.

Official Title
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Nigella Sativa Oil Extract and Xenograft Bone Graft in Treatment of Infra-bony Defects: a Combined Clinical and Histological Study

Conditions
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Localized Aggressive Periodontitis

Intervention / Treatment
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* Procedure: periodontal regenerative surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: systemically healthy patients were selected patients who had not received any medications for the previous six months that may interfere with periodontal tissue health or healing. Patients should demonstrate their ability to maintain good oral hygiene Exclusion Criteria: • Smokers and pregnant patients. Medically compromised patients and systemic conditions precluding periodontal surgery. Subjects who do not comply with oral hygiene measures as evidenced in recall visits. Restoration or caries in the site to be treated or non-vital tooth Restoration or caries in the site to be treated or non-vital tooth

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 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
Interventional Model Description: 10 patients, twenty sites with, localized aggressive periodontitis, with CAL ≥ 5 will be included in the present study. Sites will be allocated randomly to be surgically treated with, Nigella Sativa oil extract Mixed with xenograft or xenograft alone.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>10 infrabony defects treated surgically with Nigella Sativa oil extract Mixed with xenograft | Procedure: periodontal regenerative surgery<br>* Procedure/Surgery: open flap debridement Open flap for removal of diseased periodontal tissues and necrotic cementum , using xenogenic bone graft with or without Nigella Sativa oil extract<br>* Other names: periodontal surgery;|
| Placebo Comparator: control group<br>10 infrabony defects treated surgically with xenograft alone | Procedure: periodontal regenerative surgery<br>* Procedure/Surgery: open flap debridement Open flap for removal of diseased periodontal tissues and necrotic cementum , using xenogenic bone graft with or without Nigella Sativa oil extract<br>* Other names: periodontal surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing pocket depth | probing pocket depth probing pocket depth will be recorded at baseline, 3, and 6 months at the site to be treated | 6 months | 
| clinical attachment level | clinical attachment level will be recorded at baseline, 3, and 6 months at the site to be treated | 6 months | 
| bleeding on probing | bleeding on probing will be recorded at baseline, 3, and 6 months at the site to be treated | 6 months | 
| cone beam x ray measuring bone fill | bone fill will be recorded at baseline, and 6 months at the site to be treated | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nigella Sativa oil extract, Localized Aggressive Periodontitis