NCT05841589

Brief Summary

the aim of the clinical trial is to evaluate the antimicrobial efficacy of the herbal mouth rinses against chlorhexidine mouth rinse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2018

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

3.8 years

First QC Date

March 27, 2023

Last Update Submit

May 2, 2023

Conditions

Keywords

herbal mouth rinsesPomegranateCaries preventionGarlic extractGreen tea extract

Outcome Measures

Primary Outcomes (1)

  • patient satisfaction

    Child satisfaction was measured using a 5-point pictorial likert scale .This Facial image scale was suitable and easy way to evaluate patient satisfaction about taste, smell and willing to use the mouth rinse. Its format was graded from 1 to 5 while 1 is the most satisfied and 5 is the least satisfied

    Through study completion, an average of 1 month

Secondary Outcomes (1)

  • bacterial count

    1 day after rinsing

Study Arms (4)

Green tea extract mouth rinse

EXPERIMENTAL

group green tea extract

Procedure: Green tea extract mouth rinse

Garlic with lime extract mouth rinse

EXPERIMENTAL

garlic with lime extract

Procedure: Garlic with lime extract mouth rinse

Pomegranate extract mouth rinse

EXPERIMENTAL

pomegranate extract

Procedure: Pomegranate extract mouth rinse

Chlorhexidine mouth rinse

EXPERIMENTAL

chlorhexidine

Procedure: Chlorhexidine mouth rinse

Interventions

herbal extracts mouth rinse that was prepared in the microbiology laboratory

Green tea extract mouth rinse

herbal extracts mouth rinse that was prepared in the microbiology laboratory

Garlic with lime extract mouth rinse

herbal extracts mouth rinse that was prepared in the microbiology laboratory

Pomegranate extract mouth rinse

herbal extracts mouth rinse that was prepared in the microbiology laboratory

Chlorhexidine mouth rinse

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • No history of systemic disease.
  • Patients didn't received antibiotics for at least 3 months before and during the study

You may not qualify if:

  • Fixed or removable orthodontic appliances.
  • Children with intra oral abscess, oral lesions or gingival diseases.
  • Parental consent was not acquired

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shmas University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
the participant didn't know what he rinsed with the prescribed group of mouth rinse. the outcome assessor didn't know what group of mouth rinse belong to the bacterial count that was evaluated.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: the four groups of the mouth rinses were done in parallel with each other
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator and demonstrator at Pediatric Dentistry & Dental Public Health Department

Study Record Dates

First Submitted

March 27, 2023

First Posted

May 3, 2023

Study Start

February 21, 2018

Primary Completion

November 30, 2021

Study Completion

December 1, 2021

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations