Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash (RCT)

April 26, 2017 updated by: Asmaa Salah Eldin Abd El Samea Allam, Cairo University

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

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

Study Overview

Detailed Description

1. Diagnosis:

  1. Diagnostic chart (Appendix A) will be filled with personal, medical and dental history. DMF and def caries index (decayed, missing, and filled teeth).
  2. The intra oral and extra oral examinations will be made using masks, gloves, cap, goggles, gauze, medical tray, dental mirror and WHO ( World Health Organization ) probe. All materials will be packaged in sterilizations wraps and autoclave, following the required bio safety standards

2. Intervention:

• The participants included will be allocated into two groups by drawing of sealed and opaque envelopes containing the codes "A" and "B".

Experimental Group:( intervention ) Green tea with Aloe- Vera

  1. Preparation of green tea with aloe - Vera will occur under aseptic condition by pharmacist (Sargolzaie et al, 2015).
  2. Collection of saliva samples (pre-rinse) will be obtained from children who fulfilled the inclusion criteria.
  3. Distinguish odors using the Smell identification test (Doty et al. 1984). Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004).
  4. Subjects will be instructed to wash and retain the respective mouth rinse in the mouth for 40 Seconds before expectorating it.
  5. 15 min after a rinse , Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (masking effect)
  6. Patients will not allow consuming any diet or drinking orally for following 90 min.
  7. Again after 90 min, the saliva samples will be taken and inoculated on blood agar plates to determine the colony count (Velmurugan et al, 2013) and
  8. Patients with confirmed oral malodor rinsed mouthwash during 7 days (15 ml, 2x/day for 1 min.)
  9. After 7 days Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (therapeutic effect).

Comparative Group:

Commercial Chlorhexidine 0.2%

  1. Collection of saliva samples (pre-rinse) will be obtained from children who fulfilled the inclusion criteria.
  2. Distinguish odors using the Smell identification test (Doty et al. 1984). Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004).
  3. Subjects will be instructed to wash and retain the respective mouth rinse in the mouth for 40 Seconds before expectorating it.
  4. 15 min after a rinse , Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (masking effect)
  5. Patients will not allow consuming any diet or drinking orally for following 90 mins.
  6. Again after 90 min, the saliva samples will be taken and inoculated on blood agar plates to determine the colony count (Velmurugan et al, 2013) .
  7. Patients with confirmed oral malodor rinsed mouthwash during 7 days (15 ml, 2x/day for 1 min.)
  8. After 7 days Breath was scored as described by Rosenberg at rest (open mouth without breathing) and when the patients counted from 1 to 11 (Rosenberg, 1996). A 0-5 score was given (Green man et al. 2004). (therapeutic effect).

Study Type

Interventional

Enrollment (Anticipated)

27

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Oral An Dental Medicine Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. 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.

Exclusion Criteria:

  • 1. History of current or recent (at least for the past 1 month) antibiotic usage or other medications.

    2. Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.

    3. Children with known history of allergy to any mouthrinse or drug. 4. Children who wore fixed or removable orthodontic appliances.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention arm
Green Tea With Aloe Vera mouthwash twice daily for one week
measuring Tool/device Smell identification test ( organoleptic score ) (human nose) to measure of malodor which its unit 0-5 score
Other Names:
  • herbal mouthwash
Active Comparator: control arm
Chlorhexidine Mouthwash twice daily for one week
chlorohexidine mouthwash take two times per day for one week
Other Names:
  • Chemical mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral malodor
Time Frame: one week
Smell identification test (organoleptic ) (human nose)
one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Streptococcal count
Time Frame: one week
measuring Tool by using blood agar plate unit CFU/ml colony-forming units
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: sherif B eltweel, ass.prof, Cairo Unversity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

April 12, 2017

First Submitted That Met QC Criteria

April 13, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 26, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

it will be available after finished

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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