mouthwash: Garlic With Lime Juice and Chlorhexidine Mouthwash

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03105960

Collaborator

(none)

Enrollment

Location

Arms

2.7

Anticipated Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

the study about herbal mouthwash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and their effect on gingival bleeding and plaque and salivary bacteria.

Condition or Disease	Intervention/Treatment	Phase
Gingival Bleeding	Drug: garlic with lime mouth wash Drug: chlorhexidine	N/A

Detailed Description

the study about herbal mouth wash. it is clinical trial .the investigator will compare between chlorhexidine mouthwash and garlic with lime juice mouthwash.and show their effect on gingival bleeding and strepococcus bacteria present in saliva and plaque.

Preparation of garlic with lime juice will occur under aseptic condition.and give it to the first group.

provide chlorhexidine to the second group.

Collection of plaque and saliva samples will be obtained from children who fulfilled the inclusion criteria.
Asses gingival condition by asking patient.
Subjects will be instructed to rinse for 14 days, twice daily.
Morning after breakfast and night before going to bed.
With 10 ml (undiluted) of the assigned mouthwash for 30 s and then expectorate the rinse.
Again after 14 days, the saliva and plaque samples will be taken and inoculated on blood agar plates to determine the colony count and the gingival index by loe and illness will be assessed.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A Randomized Clinical Trial parallelA Randomized Clinical Trial parallel

Masking:

Double (Participant, Investigator)

Masking Description:

This was a double-blind study as the investigator was unaware about the sampling of the groups and study subjects were unaware about the mouthwash they were using

Primary Purpose:

Treatment

Official Title:

Evaluation of Garlic With Lime Juice and Chlorhexidine Mouthwash on Gingival Bleeding in Group of Egyptian Children: A Randomized Clinical Trial

Actual Study Start Date :

Mar 10, 2017

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: garlic with lime juice mouthwash garlic with lime juice mouthwash is herbal antimicrobial .children were instructed to rinse for 14 days, twice daily, ,10 ml (undiluted) for 30 second and then expectorate . To prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract.	Drug: garlic with lime mouth wash garlic with lime juice is herbal antimicrobial 10 ml (undiluted) for 30s and then expectorate for 14 days.o prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract. Other Names: herbal mouthwash
Active Comparator: chlorhexidine mouthwash chlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. it is commercial mouthwash .	Drug: chlorhexidine hlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. Other Names: antimicrobial mouthwash

Arm

Intervention/Treatment

Experimental: garlic with lime juice mouthwash

garlic with lime juice mouthwash is herbal antimicrobial .children were instructed to rinse for 14 days, twice daily, ,10 ml (undiluted) for 30 second and then expectorate . To prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract.

Drug: garlic with lime mouth wash

garlic with lime juice is herbal antimicrobial 10 ml (undiluted) for 30s and then expectorate for 14 days.o prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract.

Other Names:

herbal mouthwash

Active Comparator: chlorhexidine mouthwash

chlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. it is commercial mouthwash .

Drug: chlorhexidine

hlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days.

Other Names:

antimicrobial mouthwash

Outcome Measures

Primary Outcome Measures

gingival bleading [15 day]
bleeding of gingiva asses by yes or no

Secondary Outcome Measures

Streptococcal count in saliva and plaque [15 day]
Streptococcal count in saliva and plaque

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

Children aged between 9 and 12 years.
Children are having normal occlusion (no crowding), non-compromised oral health (brushed their teeth once-daily) using toothbrush and non-fluoridated toothpaste. And practicing no other oral hygiene measures.
Medically free history.
Absence of orthodontic appliances.

Exclusion criteria:

History of current or recent (at least for the past 1 month) antibiotic usage or other medications.
Presence of Abscess, draining sinus, cellulitis, or other conditions requiring emergency dental treatment.
not willing to comply with the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Manal Sayed Abdel Latief	Helwan	Cairo	Egypt	02

Sponsors and Collaborators

Cairo University

Investigators

Study Director: sherif B eltweel, Ass.prof, Cairo univaesity

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Description related info

Publications

Tulsani SG, Chikkanarasaiah N, Siddaiah SB, Krishnamurthy NH. The effect of Propolis and Xylitol chewing gums on salivary Streptococcus mutans count: a clinical trial. Indian J Dent Res. 2014 Nov-Dec;25(6):737-41. doi: 10.4103/0970-9290.152182.

Responsible Party:

manal sayed abdel latief, oral and dental medicine, Cairo University

ClinicalTrials.gov Identifier:

NCT03105960

Other Study ID Numbers:

151087
151087

First Posted:

Apr 10, 2017

Last Update Posted:

Apr 10, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Gingival Hemorrhage

Hemorrhage

Chlorhexidine

Study Results

No Results Posted as of Apr 10, 2017