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

Alexandria University

Status and phase: Not yet enrolling; Phase 3

Conditions: Gingivitis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05951647

0107722

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

Scaling

Placebo Comparator group

Description:

12 patients will be managed by scaling only

Treatment:

Procedure: Scaling

Scaling and Chlorohexidine mouthwash

Active Comparator group

Description:

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

Treatment:

Drug: Scaling and Chlorohexidine mouthwash

Scaling and Chamomile extract mouthwash

Experimental group

Description:

Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily.

Treatment:

Drug: Chamomile extract mouthwash

Scaling and Pomegranate peel extract mouthwash

Experimental group

Description:

Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.

Treatment:

Drug: Pomegranate peel extract mouth wash

Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash

Experimental group

Description:

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.

Treatment:

Drug: Combination of 5% chamomile extract and pomegranate peel extract mouthwash