NCT03115892

Brief Summary

The Effect of Mouthwash Containing Green Tea With Aloe Vera and Chlorhexidine Mouthwash on Oral Malodour Among a Group of Egyptian Children: Randomized Clinical Trial

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
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2017

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

April 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

April 12, 2017

Last Update Submit

April 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Oral malodor

    Smell identification test (organoleptic ) (human nose)

    one week

Secondary Outcomes (1)

  • Streptococcal count

    one week

Study Arms (2)

intervention arm

EXPERIMENTAL

Green Tea With Aloe Vera mouthwash twice daily for one week

Drug: Green Tea With Aloe Vera mouthwash

control arm

ACTIVE COMPARATOR

Chlorhexidine Mouthwash twice daily for one week

Drug: Chlorhexidine mouthwash

Interventions

measuring Tool/device Smell identification test ( organoleptic score ) (human nose) to measure of malodor which its unit 0-5 score

Also known as: herbal mouthwash
intervention arm

chlorohexidine mouthwash take two times per day for one week

Also known as: Chemical mouthwash
control arm

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. Children aged between 6 and 12 years. 2. Children having normal occlusion, non-compromised oral health (brushed their teeth once-daily) using toothbrush and non-fluoridated toothpaste. And practicing no other oral hygiene measures.

You may not qualify if:

  • \. History of current or recent (at least for the past 1 month) antibiotic usage or other medications.
  • \. Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.
  • \. Children with known history of allergy to any mouthrinse or drug. 4. Children who wore fixed or removable orthodontic appliances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral An Dental Medicine Faculty

Cairo, Egypt

Location

Related Publications (1)

  • Dadamio J, Van Tournout M, Teughels W, Dekeyser C, Coucke W, Quirynen M. Efficacy of different mouthrinse formulations in reducing oral malodour: a randomized clinical trial. J Clin Periodontol. 2013 May;40(5):505-13. doi: 10.1111/jcpe.12090. Epub 2013 Mar 13.

Related Links

MeSH Terms

Conditions

Halitosis

Interventions

Tea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • sherif B eltweel, ass.prof

    cairo unversity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Statistician only will be blind
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: two group one for intervention and one for control randomize control trail
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oral and dental medicine , principle investigator

Study Record Dates

First Submitted

April 12, 2017

First Posted

April 14, 2017

Study Start

April 1, 2017

Primary Completion

September 1, 2017

Study Completion

December 1, 2017

Last Updated

April 27, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

it will be available after finished

Locations