Clinical trial NCT05951647: The Effect of Pomegranate Peel, German Chamomile or Their Combination on Gingivitis
Official title: The Effect of Mouthwashes Containing Pomegranate Peel, German Chamomile or Their Combination in the Treatment of Gingivitis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Gingivitis
Keywords: Pomegranate peel
German chamomile
TNF-α
IL-1β
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded, parallel, randomized clinical trial
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Clinical assessment for the gingival index (GI)
timeFrame: 15 days
Secondary outcomes:
measure: Measurement of TNF-α saliva level
timeFrame: 15 days
measure: Measurement of IL1β saliva level
timeFrame: 15 days
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Pharmacy, Alexandria University
Study officials:
affiliation: Faculty of Pharmacy, Alexandria University
name: Eman Sh Anwar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Maha R Taalab, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Science, Alexandria University
name: Doaa A Ghareeb, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy, Alexandria University
name: Noha A Hamdy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy, Alexandria University
name: Marwa A Alashwah, PharmD
role: PRINCIPAL_INVESTIGATOR
References: