Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash (RCT)
Primary Purpose
Halitosis
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Green Tea With Aloe Vera mouthwash
Chlorhexidine mouthwash
Sponsored by
About this trial
This is an interventional prevention trial for Halitosis
Eligibility Criteria
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.
Sites / Locations
- Oral An Dental Medicine Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention arm
control arm
Arm Description
Green Tea With Aloe Vera mouthwash twice daily for one week
Chlorhexidine Mouthwash twice daily for one week
Outcomes
Primary Outcome Measures
Oral malodor
Smell identification test (organoleptic ) (human nose)
Secondary Outcome Measures
Streptococcal count
measuring Tool by using blood agar plate unit CFU/ml colony-forming units
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03115892
Brief Title
Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash
Acronym
RCT
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Anticipated)
Study Completion Date
December 1, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
1. Diagnosis:
Diagnostic chart (Appendix A) will be filled with personal, medical and dental history. DMF and def caries index (decayed, missing, and filled teeth).
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
Preparation of green tea with aloe - Vera will occur under aseptic condition by pharmacist (Sargolzaie et al, 2015).
Collection of saliva samples (pre-rinse) will be obtained from children who fulfilled the inclusion criteria.
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).
Subjects will be instructed to wash and retain the respective mouth rinse in the mouth for 40 Seconds before expectorating it.
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)
Patients will not allow consuming any diet or drinking orally for following 90 min.
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
Patients with confirmed oral malodor rinsed mouthwash during 7 days (15 ml, 2x/day for 1 min.)
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%
Collection of saliva samples (pre-rinse) will be obtained from children who fulfilled the inclusion criteria.
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).
Subjects will be instructed to wash and retain the respective mouth rinse in the mouth for 40 Seconds before expectorating it.
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)
Patients will not allow consuming any diet or drinking orally for following 90 mins.
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) .
Patients with confirmed oral malodor rinsed mouthwash during 7 days (15 ml, 2x/day for 1 min.)
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Halitosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
two group one for intervention and one for control randomize control trail
Masking
None (Open Label)
Masking Description
Statistician only will be blind
Allocation
Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
Green Tea With Aloe Vera mouthwash twice daily for one week
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
Chlorhexidine Mouthwash twice daily for one week
Intervention Type
Drug
Intervention Name(s)
Green Tea With Aloe Vera mouthwash
Other Intervention Name(s)
herbal mouthwash
Intervention Description
measuring Tool/device Smell identification test ( organoleptic score ) (human nose) to measure of malodor which its unit 0-5 score
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine mouthwash
Other Intervention Name(s)
Chemical mouthwash
Intervention Description
chlorohexidine mouthwash take two times per day for one week
Primary Outcome Measure Information:
Title
Oral malodor
Description
Smell identification test (organoleptic ) (human nose)
Time Frame
one week
Secondary Outcome Measure Information:
Title
Streptococcal count
Description
measuring Tool by using blood agar plate unit CFU/ml colony-forming units
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sherif B eltweel, ass.prof
Organizational Affiliation
cairo unversity
Official's Role
Study Director
Facility Information:
Facility Name
Oral An Dental Medicine Faculty
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
it will be available after finished
Citations:
PubMed Identifier
23489103
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/23489103?tool=bestpractice.bmj.com
Description
paper
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Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash
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