Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash

Phase 1

• Conditions: Halitosis
• Interventions: Drug: Chlorhexidine mouthwash; Drug: Green Tea With Aloe Vera mouthwash

• Registration Number: NCT03115892
• Lead Sponsor: Cairo University

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:

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2017-04
• Study Start: 2017-04-01
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-14
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27
• Primary Completion: 2017-09-01
• Study Completion: 2017-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control arm	Chlorhexidine mouthwash	Chlorhexidine Mouthwash twice daily for one week
intervention arm	Green Tea With Aloe Vera mouthwash	Green Tea With Aloe Vera mouthwash twice daily for one week

Primary Outcome Measures

Name	Time	Method
Oral malodor	one week	Smell identification test (organoleptic ) (human nose)

Secondary Outcome Measures

Name	Time	Method
Streptococcal count	one week	measuring Tool by using blood agar plate unit CFU/ml colony-forming units

Trial Locations

Locations (1)

Oral An Dental Medicine Faculty; 🇪🇬 Cairo, Egypt