The efficacy of honey mouth-rinse on the intra-oral flora
| ISRCTN | ISRCTN38327678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38327678 |
| Secondary identifying numbers | 18-1728 |
- Submission date
- 19/12/2019
- Registration date
- 17/01/2020
- Last edited
- 17/01/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Damascus university
Faculty of dental medicine
Department of periodontology
Damascus
00000
Syria
 ORCID ID |
0000-0002-9147-189X |
|---|---|
| Phone | +963 932985177 |
| bhaa.alhafar@gmail.com |
Study information
| Study design | Interventional randomised cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | No participant information sheet available |
| Scientific title | Randomized controlled trial to evaluate the efficacy of honey mouth-rinse on the intra-oral flora: a cross-over study |
| Study objectives | The honey mouth rinse has an antimicrobial efficacy on the intra oral flora |
| Ethics approval(s) | Approved 16/04/2013, Ethical Committee of the Faculty of Dental Medicine (Damascus University, Damascus, Syria; +963 113341864; manager@hcsr.gov.sy), ref: none |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2018 |
| Completion date | 01/03/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | Healthy volunteers with good oral hygiene |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 01/02/2019 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
00000
Syria
Sponsor information
University/education
Almazzah St.
Damascus
00000
Syria
| Phone | +963 0114442727 |
|---|---|
| info@damascusuniversity.edu.sy | |
| Website | http://damascusuniversity.edu.sy/index.php?lang=1 |
"ROR" |
https://ror.org/03m098d13 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. |
Editorial Notes
17/01/2020: Trial’s existence confirmed by Damascus University Ethics Committee
