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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05951647
Recruitment Status : Not yet recruiting
First Posted : July 19, 2023
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
Alexandria University

Study Description
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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:
  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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-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
Estimated Study Start Date : July 11, 2023
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Clinical assessment for the gingival index (GI) [ Time Frame: 15 days ]
    The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively.


Secondary Outcome Measures :
  1. Measurement of TNF-α saliva level [ Time Frame: 15 days ]
    TNF-α saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.

  2. Measurement of IL1β saliva level [ Time Frame: 15 days ]
    IL1β saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05951647


Contacts
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Contact: Noha A Hamdy, PhD 1005182151 ext +20 noha.alaaeldine@alexu.edu.eg
Contact: Marwa A Alashwah, PharmD 1223467205 ext +20 gs-marwa.alashwah@alexu.edu.eg

Locations
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Egypt
Faculty of Pharmacy, Alexandria University
Alexandria, Egypt, 21521
Contact: Noha A Hamdy, PhD    1005182151 ext +20    noha.alaaeldine@alexu.edu.eg   
Sponsors and Collaborators
Alexandria University
Investigators
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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
More Information
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Responsible Party: Alexandria University
ClinicalTrials.gov Identifier: NCT05951647    
Other Study ID Numbers: 0107722
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Alexandria University:
Pomegranate peel
German chamomile
TNF-α
IL-1β
Additional relevant MeSH terms:
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Gingivitis
Infections
Gingival Diseases
 Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases