Back to results

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

Primary Purpose

Gingivitis

Status

Not yet recruiting

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Chamomile extract mouthwash

Pomegranate peel extract mouth wash

Combination of 5% chamomile extract and pomegranate peel extract mouthwash

Scaling

Scaling and Chlorohexidine mouthwash

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring Pomegranate peel, German chamomile, TNF-α, IL-1β

Eligibility Criteria

25 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Faculty of Pharmacy, Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Scaling

Scaling and Chlorohexidine mouthwash

Scaling and Chamomile extract mouthwash

Scaling and Pomegranate peel extract mouthwash

Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash

Arm Description

12 patients will be managed by scaling only

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

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

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

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.

Outcomes

Primary Outcome Measures

Clinical assessment for the gingival index (GI)

The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively.

Secondary Outcome Measures

Measurement of TNF-α saliva level

TNF-α saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.

Measurement of IL1β saliva level

IL1β saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.

Full Information

NCT ID

NCT05951647

First Posted

July 11, 2023

Last Updated

July 11, 2023

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT05951647

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 11, 2023 (Anticipated)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gingivitis

Keywords

Pomegranate peel, German chamomile, TNF-α, IL-1β

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Double-blinded, parallel, randomized clinical trial

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Scaling

Arm Type

Placebo Comparator

Arm Description

12 patients will be managed by scaling only

Arm Title

Scaling and Chlorohexidine mouthwash

Arm Type

Active Comparator

Arm Description

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

Arm Title

Scaling and Chamomile extract mouthwash

Arm Type

Experimental

Arm Description

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

Arm Title

Scaling and Pomegranate peel extract mouthwash

Arm Type

Experimental

Arm Description

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

Arm Title

Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Chamomile extract mouthwash

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Pomegranate peel extract mouth wash

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Combination of 5% chamomile extract and pomegranate peel extract mouthwash

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Scaling

Intervention Description

Patients will be managed by scaling

Intervention Type

Drug

Intervention Name(s)

Scaling and Chlorohexidine mouthwash

Intervention Description

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

Primary Outcome Measure Information:

Title

Clinical assessment for the gingival index (GI)

Description

The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively.

Time Frame

15 days

Secondary Outcome Measure Information:

Title

Measurement of TNF-α saliva level

Description

TNF-α saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.

Time Frame

15 days

Title

Measurement of IL1β saliva level

Description

IL1β saliva level will be measured before treatment, 7 days, and 15 days after treatment respectively.

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noha A Hamdy, PhD

Phone

1005182151

Ext

+20

noha.alaaeldine@alexu.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Marwa A Alashwah, PharmD

Phone

1223467205

Ext

+20

gs-marwa.alashwah@alexu.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eman Sh Anwar, PhD

Organizational Affiliation

Faculty of Pharmacy, Alexandria University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Maha R Taalab, PhD

Organizational Affiliation

Alexandria University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Doaa A Ghareeb, PhD

Organizational Affiliation

Faculty of Science, Alexandria University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Noha A Hamdy, PhD

Organizational Affiliation

Faculty of Pharmacy, Alexandria University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marwa A Alashwah, PharmD

Organizational Affiliation

Faculty of Pharmacy, Alexandria University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Pharmacy, Alexandria University

City

Alexandria

ZIP/Postal Code

21521

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noha A Hamdy, PhD

Phone

1005182151

Ext

+20

noha.alaaeldine@alexu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs