Effect of Spirulina on Periodontitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the clinical and immunological effect of spirulina in treatment of stage II periodontitis.

Detailed Description
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In this study, the investigators tested the effect of spirulina gel as adjunctive of scaling and root planing in treatment of stage II, grade B periodontitis in term of probing pocket depth reduction, mean gain in clinical attachment level, and level of interleukin 6.

Official Title
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Effect of Locally Delivered Spirulina Gel on Treatment of Stage II, Grade B Periodontitis

Conditions
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Periodontitis

Intervention / Treatment
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* Drug: spirulina gel
* Procedure: SRP of all teeth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the patients suffer from stage II, grade B periodonitis with attachment loss 3-4 mm and probing pocket depth ≤ 5mm. Exclusion Criteria: Any systemic disease that affects the periodontium. · Pregnant, postmenopausal women. · People who take anti-inflammatory drugs, antibiotics, or vitamins within the previous 3 month. People who use mouth washes regularly · Participation in other clinical trials.

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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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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: oral hygiene instructions and SRP of all teeth plus placebo gel.<br> | Procedure: SRP of all teeth<br>* Patients received oral hygiene instructions and SRP of all teeth.<br>|
| Active Comparator: oral hygiene instructions and SRP of all teeth, followed by insertion of the spirulina gel.<br> | Drug: spirulina gel<br>* Patient were received spirulina gel in diseased sites. The process will be repeated at 7, 14, 21 days.<br>Procedure: SRP of all teeth<br>* Patients received oral hygiene instructions and SRP of all teeth.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level | Clinical attachment level was measured at baseline, 1 and 3 months after gel application. | 3 months | 
| Probing pocket depth | Probing pocket depth was measured at baseline, 1 and 3 months after gel application. | 3 months | 
| Interleukin 6. | Enzyme linked immune-assay for the quantitative measurement of interleukin 6 concentration in gingival cervicular fluid at baseline, 1 and 3 months after gel application. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque Index | Plaque index was measured at baseline and at 1, and 3-months post treatment. | 3 months | 
| Gingival index | Gingival index was measured at baseline and at 1, and 3-months post treatment. | 3 months |