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

Cairo University (CU)

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Halitosis

Treatments: Drug: Green Tea With Aloe Vera mouthwash; Drug: Chlorhexidine mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT03115892

pedodontics

Details and patient eligibility

About

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

Full description

1. Diagnosis:

2. Diagnostic chart (Appendix A) will be filled with personal, medical and dental history. DMF and def caries index (decayed, missing, and filled teeth).

3. 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

4. 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).

Enrollment: 27 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

intervention arm

Experimental group

Description:

Green Tea With Aloe Vera mouthwash twice daily for one week

Treatment:

Drug: Green Tea With Aloe Vera mouthwash

control arm

Active Comparator group

Description:

Chlorhexidine Mouthwash twice daily for one week

Treatment:

Drug: Chlorhexidine mouthwash