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

NCT ID: NCT05951647

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-11

Study Completion Date

2023-11-30

Brief Summary

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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

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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

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Gingivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded, parallel, randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Scaling

12 patients will be managed by scaling only

Group Type PLACEBO_COMPARATOR

Scaling

Intervention Type PROCEDURE

Patients will be managed by scaling

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.

Group Type ACTIVE_COMPARATOR

Scaling and Chlorohexidine mouthwash

Intervention Type DRUG

scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.

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.

Group Type EXPERIMENTAL

Chamomile extract mouthwash

Intervention Type DRUG

5% chamomile extract mouthwash in a dose of 15 ml twice daily.

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.

Group Type EXPERIMENTAL

Pomegranate peel extract mouth wash

Intervention Type DRUG

5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.

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.

Group Type EXPERIMENTAL

Combination of 5% chamomile extract and pomegranate peel extract mouthwash

Intervention Type DRUG

Use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.

Interventions

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Chamomile extract mouthwash

5% chamomile extract mouthwash in a dose of 15 ml twice daily.

Intervention Type DRUG

Pomegranate peel extract mouth wash

5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.

Intervention Type 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.

Intervention Type DRUG

Scaling

Patients will be managed by scaling

Intervention Type PROCEDURE

Scaling and Chlorohexidine mouthwash

scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eman Sh Anwar, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy, Alexandria University

Maha R Taalab, PhD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Doaa A Ghareeb, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Science, Alexandria University

Noha A Hamdy, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy, Alexandria University

Marwa A Alashwah, PharmD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy, Alexandria University

Locations

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Faculty of Pharmacy, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Noha A Hamdy, PhD

Role: CONTACT

1005182151 ext. +20

Marwa A Alashwah, PharmD

Role: CONTACT

1223467205 ext. +20

Facility Contacts

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Noha A Hamdy, PhD

Role: primary

1005182151 ext. +20

Other Identifiers

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0107722

Identifier Type: -

Identifier Source: org_study_id

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