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

Phase 3

Not yet recruiting

• Conditions: Gingivitis
• Interventions: Drug: Pomegranate peel extract mouth wash; Procedure: Scaling; Drug: Scaling and Chlorohexidine mouthwash; Drug: Chamomile extract mouthwash; Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash

• Registration Number: NCT05951647
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-11
• Study First Submitted: 2023-07-11
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-19
• Last Update Posted: 2023-07-19
• Primary Completion: 2023-10
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scaling and Pomegranate peel extract mouthwash	Pomegranate peel extract mouth wash	Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
Scaling	Scaling	12 patients will be managed by scaling only
Scaling and Chlorohexidine mouthwash	Scaling and Chlorohexidine mouthwash	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	Chamomile extract mouthwash	Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily.
Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash	Combination of 5% chamomile extract and pomegranate peel extract mouthwash	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Pharmacy, Alexandria University; 🇪🇬 Alexandria, Egypt