The Effect of Pomegranate Peel, German Chamomile or Their Combination on Gingivitis

Study Overview
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Brief Summary
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The aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing German chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. The response will be assessed clinically and by suitable biochemical parameters.

Detailed Description
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Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University All participants should agree to take part in this clinical study and will provide informed consent. Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University. The 60 participants will be randomly assigned into 5 groups. Group 1: Patients will be managed by scaling. Group 2: Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. Group 3: Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. Group 4: Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. Group 5: Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. All patients will be submitted to: Full patient history and clinical examination. Gingival index will be measured Saliva samples will be obtained in order to conduct ELISA for the selected biomarkers. Different mouthwashes will be provided to patients. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Results, conclusion, discussion and recommendations will be given.

Official Title
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The Effect of Mouthwashes Containing Pomegranate Peel, German Chamomile or Their Combination in the Treatment of Gingivitis

Conditions
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Gingivitis

Intervention / Treatment
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* Drug: Chamomile extract mouthwash
* Drug: Pomegranate peel extract mouth wash
* Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash
* Procedure: Scaling
* Drug: Scaling and Chlorohexidine mouthwash


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 25-50 Patients with plaque induced gingivitis. Exclusion Criteria: Patients with systemic diseases (diabetes, leukemia, anemia) Smokers Pregnant females Patients receiving orthodontic treatment

Ages Eligible for Study
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Minimum Age: 25 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
Interventional Model Description: Double-blinded, parallel, randomized clinical trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Scaling<br>12 patients will be managed by scaling only | Procedure: Scaling<br>* Patients will be managed by scaling<br>|
| Active Comparator: Scaling and Chlorohexidine mouthwash<br>Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. | Drug: Scaling and Chlorohexidine mouthwash<br>* scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.<br>|
| Experimental: Scaling and Chamomile extract mouthwash<br>Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. | Drug: Chamomile extract mouthwash<br>* 5% chamomile extract mouthwash in a dose of 15 ml twice daily.<br>|
| Experimental: Scaling and Pomegranate peel extract mouthwash<br>Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. | Drug: Pomegranate peel extract mouth wash<br>* 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.<br>|
| Experimental: Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash<br>Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. | Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash<br>* Use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical assessment for the gingival index (GI) | The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of TNF-α saliva level | TNF-α saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively. | 15 days | 
| Measurement of IL1β saliva level | IL1β saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pomegranate peel, German chamomile, TNF-α, IL-1β