NCT03105960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 21, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 10, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

April 10, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

March 21, 2017

Last Update Submit

April 4, 2017

Conditions

Gingival Bleeding

Outcome Measures

Primary Outcomes (1)

  • gingival bleading

    bleeding of gingiva asses by yes or no

    15 day

Secondary Outcomes (1)

  • Streptococcal count in saliva and plaque

    15 day

Study Arms (2)

garlic with lime juice mouthwash

EXPERIMENTAL

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

chlorhexidine mouthwash

ACTIVE COMPARATOR

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

Interventions

garlic with lime mouth washDRUG

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.

Also known as: herbal mouthwash
garlic with lime juice mouthwash
chlorhexidineDRUG

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

Also known as: antimicrobial mouthwash
chlorhexidine mouthwash

Eligibility Criteria

Age9 Years - 12 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsEgyptian children
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manal Sayed Abdel Latief

Helwan, Cairo Governorate, 02, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 25728105BACKGROUND

Related Links

MeSH Terms

Conditions

Gingival Hemorrhage

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Oral HemorrhageMouth DiseasesStomatognathic DiseasesGingival DiseasesPeriodontal DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • sherif B eltweel, Ass.prof

    Cairo univaesity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Randomized Clinical Trial parallel
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
oral and dental medicine

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 10, 2017

Study Start

March 10, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

April 10, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

it will be available when it finish

Locations

EG(1)