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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaling | Placebo Comparator | 12 patients will be managed by scaling only |
|
| Scaling and Chlorohexidine mouthwash | Active Comparator | Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. |
|
| Scaling and Chamomile extract mouthwash | Experimental | Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily. |
|
| Scaling and Pomegranate peel extract mouthwash | Experimental | Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. |
|
| Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chamomile extract mouthwash | Drug | 5% chamomile extract mouthwash in a dose of 15 ml twice daily. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha A Hamdy, PhD | Contact | 1005182151 | +20 | noha.alaaeldine@alexu.edu.eg |
| Marwa A Alashwah, PharmD | Contact | 1223467205 | +20 | gs-marwa.alashwah@alexu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Eman Sh Anwar, PhD | Faculty of Pharmacy, Alexandria University | Principal Investigator |
| Maha R Taalab, PhD | Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Alexandria University | Alexandria | 21521 | Egypt |
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Double-blinded, parallel, randomized clinical trial
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| Pomegranate peel extract mouth wash | Drug | 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily. |
|
| Combination of 5% chamomile extract and pomegranate peel extract mouthwash | Drug | Use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. |
|
| Scaling | Procedure | Patients will be managed by scaling |
|
| Scaling and Chlorohexidine mouthwash | Drug | scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily. |
|
| 15 days |
| Doaa A Ghareeb, PhD |
| Faculty of Science, Alexandria University |
| Principal Investigator |
| Noha A Hamdy, PhD | Faculty of Pharmacy, Alexandria University | Principal Investigator |
| Marwa A Alashwah, PharmD | Faculty of Pharmacy, Alexandria University | Principal Investigator |
| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000713170 | Chamomile extract |
| D014080 | Tooth Exfoliation |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
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