NCT05951647

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gingivitis

Interventions

Type	Name	Description
DRUG	Chamomile extract mouthwash	5% chamomile extract mouthwash in a dose of 15 ml twice daily.
DRUG	Pomegranate peel extract mouth wash	5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
DRUG	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.

Timeline

• Start date: 2023-07-11
• Primary completion: 2023-10-01
• Completion: 2023-11-01
• First posted: 2023-07-19
• Last updated: 2023-07-19

Locations

1 site across 1 country: Egypt