Gingivitis
Conditions
Keywords
Pomegranate peel, German chamomile, TNF-α, IL-1β
Brief summary
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
1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University. 4. 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. 5. 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. 6. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 7. Results, conclusion, discussion and recommendations will be given.
Interventions
DRUGChamomile extract mouthwash
5% chamomile extract mouthwash in a dose of 15 ml twice daily.
DRUGPomegranate peel extract mouth wash
5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
DRUGCombination of 5% chamomile extract and pomegranate peel extract mouthwash
Use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.
PROCEDUREScaling
Patients will be managed by scaling
DRUGScaling and Chlorohexidine mouthwash
scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Double-blinded, parallel, randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical assessment for the gingival index (GI) | 15 days | The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of TNF-α saliva level | 15 days | TNF-α saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively. |
| Measurement of IL1β saliva level | 15 days | IL1β saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively. |
Countries
Egypt
Contacts
Primary ContactNoha A Hamdy, PhD
Backup ContactMarwa A Alashwah, PharmD
Outcome results
None listed