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

Sponsor

Alexandria University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05951647

Collaborator

(none)

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gingivitis	Drug: Chamomile extract mouthwash Drug: Pomegranate peel extract mouth wash Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash Procedure: Scaling Drug: Scaling and Chlorohexidine mouthwash	Phase 3

Detailed Description

Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University
All participants should agree to take part in this clinical study and will provide informed consent.
Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University.
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.

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.

Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
Results, conclusion, discussion and recommendations will be given.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-blinded, parallel, randomized clinical trialDouble-blinded, parallel, randomized clinical trial

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 11, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Pharmacy, Alexandria University	Alexandria		Egypt	21521

Sponsors and Collaborators

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