NCT05951647

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 11, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 19, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

3 months

First QC Date

July 11, 2023

Last Update Submit

July 11, 2023

Conditions

Gingivitis

Keywords

Pomegranate peelGerman chamomileTNF-αIL-1β

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment for the gingival index (GI)

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

    15 days

Secondary Outcomes (2)

  • Measurement of TNF-α saliva level

    15 days

  • Measurement of IL1β saliva level

    15 days

Study Arms (5)

Scaling

PLACEBO COMPARATOR

12 patients will be managed by scaling only

Procedure: Scaling

Scaling and Chlorohexidine mouthwash

ACTIVE COMPARATOR

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 Chamomile extract mouthwash

EXPERIMENTAL

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

Scaling and Pomegranate peel extract mouthwash

EXPERIMENTAL

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

Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash

EXPERIMENTAL

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

Interventions

Chamomile extract mouthwashDRUG

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

Scaling and Chamomile extract mouthwash
Pomegranate peel extract mouth washDRUG

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

Scaling and Pomegranate peel extract mouthwash
Combination of 5% chamomile extract and pomegranate peel extract mouthwashDRUG

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

Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash
ScalingPROCEDURE

Patients will be managed by scaling

Scaling
Scaling and Chlorohexidine mouthwashDRUG

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

Scaling and Chlorohexidine mouthwash

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 25-50
  • Patients with plaque induced gingivitis.

You may not qualify if:

  • Patients with systemic diseases (diabetes, leukemia, anemia)
  • Smokers
  • Pregnant females
  • Patients receiving orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Pharmacy, Alexandria University

Alexandria, 21521, Egypt

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Chamomile extractTooth Exfoliation

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Noha A Hamdy, PhD

CONTACT

1005182151noha.alaaeldine@alexu.edu.eg

Marwa A Alashwah, PharmD

CONTACT

1223467205gs-marwa.alashwah@alexu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded, parallel, randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 19, 2023

Study Start

July 11, 2023

Primary Completion

October 1, 2023

Study Completion

November 1, 2023

Last Updated

July 19, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)