Condition category
Oral Health
Date applied
19/12/2019
Date assigned
17/01/2020
Last edited
17/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

http://damascusuniversity.edu.sy/index.php?lang=1

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

Publication citations

Additional files

Editorial Notes

17/01/2020: Trial’s existence confirmed by Damascus University Ethics Committee