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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Gingivitis
• Intervention / Treatment: Procedure: Scaling; Drug: Scaling and Chlorohexidine mouthwash; Drug: Chamomile extract mouthwash; Drug: Pomegranate peel extract mouth wash; Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Noha A Hamdy, PhD; Phone Number: +20 1005182151; Email: noha.alaaeldine@alexu.edu.eg
• Study Contact Backup: Name: Marwa A Alashwah, PharmD; Phone Number: +20 1223467205; Email: gs-marwa.alashwah@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21521
    • Faculty of Pharmacy, Alexandria University
    • Contact: Noha A Hamdy, PhD; Phone Number: +20 1005182151; Email: noha.alaaeldine@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Scaling; 12 patients will be managed by scaling only	Procedure: Scaling; Patients will be managed by scaling
Active Comparator: 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.	Drug: Scaling and Chlorohexidine mouthwash; scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.
Experimental: Scaling and Chamomile extract mouthwash; Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily.	Drug: Chamomile extract mouthwash; 5% chamomile extract mouthwash in a dose of 15 ml twice daily.
Experimental: Scaling and Pomegranate peel extract mouthwash; Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash 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.
Experimental: Scaling and Chamomile extract mixed with 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	15 days

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Eman Sh Anwar, PhD, Faculty of Pharmacy, Alexandria University; Principal Investigator: Maha R Taalab, PhD, Alexandria University; Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Estimated): July 11, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: July 11, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 19, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: TNF-α; Pomegranate peel; IL-1β; German chamomile
• Additional Relevant MeSH Terms: Infections; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Gingivitis
• Other Study ID Numbers: 0107722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No