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

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05951647
• Other study ID #: 0107722
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 11, 2023
• Est. completion date: November 2023

Study information

• Verified date: July 2023
• Source: Alexandria University
• Contact: Noha A Hamdy, PhD
• Phone: 1005182151
• Email: noha.alaaeldine[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: November 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis

Intervention

Drug:
• Chamomile extract mouthwash
5% chamomile extract mouthwash in a dose of 15 ml twice daily.
• Pomegranate peel extract mouth wash
5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
• Combination 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.

Procedure:
• Scaling
Patients will be managed by scaling

Drug:
• Scaling and Chlorohexidine mouthwash
scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Measurement of TNF-a saliva level	TNF-a saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.	15 days
Secondary	Measurement of IL1ß saliva level	IL1ß saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.	15 days