Gingival BleedingmouthwashNCT03105960
Garlic With Lime Juice and Chlorhexidine Mouthwash
A study testing garlic with lime mouth wash and chlorhexidine in people with Gingival Bleeding, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Bleeding
- What is being tested?
- garlic with lime mouth wash and chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2017to 1 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingival Bleeding
- Being tested
- garlic with lime mouth wash, chlorhexidine
- Medical subject headings
- Gingival Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
garlic with lime mouth washDrug
Also called herbal mouthwash
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.
chlorhexidineDrug
Also called antimicrobial mouthwash
hlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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
. Receives: Drug: chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival bleading
bleeding of gingiva asses by yes or no
Measured: 15 day
Secondary outcomes (1)
Streptococcal count in saliva and plaque
Streptococcal count in saliva and plaque
Measured: 15 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start10 Mar 2017
- Primary completion1 Jun 2017 (estimated)
- Study completion1 Jun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival BleedingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Clinical Trial parallel
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, manal sayed abdel latief, Cairo University
- Investigators
- sherif B eltweel, Ass.prof, Study director, Cairo univaesity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105960
- Sponsor's protocol ID
- 151087
- Other IDs
- 151087
- Acronym
- mouthwash
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2017
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: it will be available when it finish
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.
PubMed 25728105
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Garlic With Lime Juice and Chlorhexidine Mouthwash on Gingival Bleeding in Group of Egyptian Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03105960
- Acronym / sponsor ID
- mouthwash / 151087
- Conditions
- Gingival Bleeding
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 1 Jun 2017 (estimated)
- Study completion
- 1 Jun 2017 (estimated)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Randomized Clinical Trial parallel
| Arm | Type | Receives |
|---|---|---|
| garlic with lime juice mouthwash | Experimental | Drug: garlic with lime mouth washgarlic 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 mouthwash | Active comparator | Drug: chlorhexidinechlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. it is commercial mouthwash . |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| garlic with lime mouth washAlso: herbal mouthwashgarlic 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. | Drug | garlic with lime juice mouthwash |
| chlorhexidineAlso: antimicrobial mouthwashhlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days. | Drug | chlorhexidine mouthwash |
Primary outcome
gingival bleading
Time frame: 15 day
bleeding of gingiva asses by yes or no
1 secondary outcome
Streptococcal count in saliva and plaque
Time frame: 15 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 25728105Tulsani 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.
- Description related infoLink provided by the sponsor.
- Individual participant dataSharing planned: No. it will be available when it finish
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sherif B eltweel, Ass.prof study director
Cairo univaesity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing garlic with lime mouth wash and chlorhexidine in people with Gingival Bleeding, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival bleading (time frame: 15 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105960, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.