Plain English Summary
Background and study aims
Mouth rinses are considered as an essential mean of oral hygiene, but due to the side effects of its chemical ingredients the search for a natural alternative had begun. Honey is one of these alternatives and has been long known for its antimicrobial properties.
Aims: This study aimed to evaluate the efficacy of Syrian Honey mouth rinse on salivary flora in comparison with Chlorhexidine 0.12% mouth rinse.
Who can participate?
Healthy adults with good oral hygiene.
What does the study involve?
Participants are randomly allocated to use the products, Honey mouth rinse, Chlorhexidine 0.12% mouth rinse, or placebo, in a different order. Participants use each product once for 30 seconds, after seven days they use the next product etc. One minute and 30 minutes after using the product a saliva sample will be collected.
What are the possible benefits and risks of participating?
Possible benefit is finding an alternative for the chemical mouth rinse by using a certain concentration of honey. There are no risks from participating at all, all three groups of treatment used approved materials which causes no harms for patients, groups A commercial chlorhexidine, group B honey mouth rinse, group C distilled water.
Where is the study run from?
Damascus University - Faculty of Dental Medicine, Syria
When is the study starting and how long is it expected to run for?
January 2019 to March 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Mhd Bahaa Aldin Alhaffar
bhaa.alhafar@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mhd Bahaa Aldin Alhaffar
ORCID ID
https://orcid.org/0000-0002-9147-189X
Contact details
Damascus university
Faculty of dental medicine
Department of periodontology
Damascus
00000
Syria
+963 932985177
bhaa.alhafar@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
18-1728
Study information
Scientific title
Randomized controlled trial to evaluate the efficacy of honey mouth-rinse on the intra-oral flora: a cross-over study
Acronym
Study hypothesis
The honey mouth rinse has an antimicrobial efficacy on the intra oral flora
Ethics approval
Approved 16/04/2013, Ethical Committee of the Faculty of Dental Medicine (Damascus University, Damascus, Syria; +963 113341864; manager@hcsr.gov.sy), ref: none
Study design
Interventional randomised cross over trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
No participant information sheet available
Condition
Intra oral flora
Intervention
The effectiveness of Syrian honey mouth rinse on salivary floral bacteria was investigated at the inhibitory concentration suitable for use as a mouth rinse define by diffusion method on Muller-Hinton agar to reach the suitable concentration which is found to be 50%. The disinfecting effect of this 50% solution was studied in a triple blinded study in comparison with Chlorhexidine 0.12%, and distilled water as control. Each participant used the three solutions once for 30 sec 7 days apart. Then the saliva colony forming unit (CFU) count was measured after rinsing by 1 and 30 min.
Group A: honey mouth rinse 50%.
Group B: chlorhexidine 0.12%
Group C: control (distilled water)
Randomization:
The researcher prepared special cards numbered from (1-40) and each patient took one card randomly from a black box, each card had a letter (A,B OR C). each letter refers to a certain treatment group, nether the researcher, the volunteer or the statistician know what the letter refers to until the end of the data analysis.
Intervention type
Supplement
Phase
Drug names
Primary outcome measure
The colony forming unit counts (CFU) measured using saliva samples collected from each patient on three different timepoints (before the test, after one minute of the mouth rinse, after 30 minutes of mouth rinse)
Secondary outcome measures
Oral health index collected using oral examination and with UNC15 probe (university of North Carolina). Oral data collected from each patient on three different timepoints (before the test, after one minute of the mouth rinse, after 30 minutes of mouth rinse).
1. Plaque index (PI)
2. Gingival index (GI)
3. Decayed, missing, filled teeth index
Overall trial start date
01/09/2018
Overall trial end date
01/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy volunteers with good oral hygiene
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2019
Recruitment end date
01/02/2019
Locations
Countries of recruitment
Syria
Trial participating centre
Damascus University - Faculty of Dental Medicine
Almazzah St.
Damascus
00000
Syria
Sponsor information
Organisation
Damascus University
Sponsor details
Almazzah St.
Damascus
00000
Syria
+963 0114442727
info@damascusuniversity.edu.sy
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Intention to publish date
01/02/2020
Participant level data
Available on request
Basic results (scientific)
Publication list