Green Tea With Aloe Vera Mouthwash and Chlorohexidine Mouthwash

NCT ID: NCT03115892

Last Updated: 2017-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2017-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Halitosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

two group one for intervention and one for control randomize control trail
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Statistician only will be blind

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention arm

Green Tea With Aloe Vera mouthwash twice daily for one week

Group Type EXPERIMENTAL

Green Tea With Aloe Vera mouthwash

Intervention Type DRUG

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

control arm

Chlorhexidine Mouthwash twice daily for one week

Group Type ACTIVE_COMPARATOR

Chlorhexidine mouthwash

Intervention Type DRUG

chlorohexidine mouthwash take two times per day for one week

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Green Tea With Aloe Vera mouthwash

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

Intervention Type DRUG

Chlorhexidine mouthwash

chlorohexidine mouthwash take two times per day for one week

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

herbal mouthwash Chemical mouthwash

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Asmaa Salah Eldin Abd El Samea Allam

oral and dental medicine , principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sherif B eltweel, ass.prof

Role: STUDY_DIRECTOR

cairo unversity

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oral An Dental Medicine Faculty

Cairo, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23489103 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

pedodontics

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.