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Garlic With Lime Juice and Chlorhexidine Mouthwash (mouthwash)

Primary Purpose

Gingival Bleeding

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
garlic with lime mouth wash
chlorhexidine
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Bleeding

Eligibility Criteria

9 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  1. Children aged between 9 and 12 years.
  2. 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.
  3. Medically free history.
  4. Absence of orthodontic appliances.

Exclusion criteria:

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

Sites / Locations

  • Manal Sayed Abdel Latief

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

garlic with lime juice mouthwash

chlorhexidine mouthwash

Arm Description

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.

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

Outcomes

Primary Outcome Measures

gingival bleading
bleeding of gingiva asses by yes or no

Secondary Outcome Measures

Streptococcal count in saliva and plaque
Streptococcal count in saliva and plaque

Full Information

First Posted
March 21, 2017
Last Updated
April 4, 2017
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03105960
Brief Title
Garlic With Lime Juice and Chlorhexidine Mouthwash
Acronym
mouthwash
Official Title
Evaluation of Garlic With Lime Juice and Chlorhexidine Mouthwash on Gingival Bleeding in Group of Egyptian Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Anticipated)
Study Completion Date
June 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A Randomized Clinical Trial parallel
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
garlic with lime juice mouthwash
Arm Type
Experimental
Arm Description
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.
Arm Title
chlorhexidine mouthwash
Arm Type
Active Comparator
Arm Description
chlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. it is commercial mouthwash .
Intervention Type
Drug
Intervention Name(s)
garlic with lime mouth wash
Other Intervention Name(s)
herbal mouthwash
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
chlorhexidine
Other Intervention Name(s)
antimicrobial mouthwash
Intervention Description
hlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days.
Primary Outcome Measure Information:
Title
gingival bleading
Description
bleeding of gingiva asses by yes or no
Time Frame
15 day
Secondary Outcome Measure Information:
Title
Streptococcal count in saliva and plaque
Description
Streptococcal count in saliva and plaque
Time Frame
15 day

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Egyptian children
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sherif B eltweel, Ass.prof
Organizational Affiliation
Cairo univaesity
Official's Role
Study Director
Facility Information:
Facility Name
Manal Sayed Abdel Latief
City
Helwan
State/Province
Cairo
ZIP/Postal Code
02
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
it will be available when it finish
Citations:
PubMed Identifier
25728105
Citation
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.
Results Reference
background
Links:
URL
http://doi.org/10.4103/0970-9290.152182
Description
Description related info

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Garlic With Lime Juice and Chlorhexidine Mouthwash

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