Garlic With Lime Juice and Chlorhexidine Mouthwash (mouthwash)

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

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.

Study Overview

• Status: Unknown
• Conditions: Gingival Bleeding
• Intervention / Treatment: Drug: garlic with lime mouth wash; Drug: chlorhexidine

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.

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

   provide chlorhexidine to the second group.

2. Collection of plaque and saliva samples will be obtained from children who fulfilled the inclusion criteria.
3. Asses gingival condition by asking patient.
4. Subjects will be instructed to rinse for 14 days, twice daily.
5. Morning after breakfast and night before going to bed.
6. With 10 ml (undiluted) of the assigned mouthwash for 30 s and then expectorate the rinse.
7. 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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Helwan, Cairo, Egypt, 02
      • Manal Sayed Abdel Latief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gingival bleading	bleeding of gingiva asses by yes or no	15 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Streptococcal count in saliva and plaque	Streptococcal count in saliva and plaque	15 day

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: sherif B eltweel, Ass.prof, Cairo univaesity

Publications and helpful links

General 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.

Helpful Links

• Description related info

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2017
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: March 21, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Gingival Diseases; Oral Hemorrhage; Hemorrhage; Gingival Hemorrhage; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 151087 (Registry Identifier: manal sayed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: it will be available when it finish

Drug and device information, study documents

• 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