Protocol summary
-
Study aim
-
In according to previous studies herbal mouth washes had obvious beneficial effects on dental caries and gingival health. In according to harmful effect of chemical mouth washes, herbal mouth washes production with minimal side effects and affordable for all of society population is very important. The aim of this study is evaluation of glycyrrhiza glabra, salvia officinalis and zinc extract mouth washes individually and in combination on streptococcus mutans growth, carious bacteria reduction and gingival health.
-
Design
-
Dental students voluntary participated to study are divided into five equal groups.By selecting the mouthwash blindly, they entered the mouthwashes and control group (water). The researcher is also unaware of the type of mouthwash and prescribes it as a code.
-
Settings and conduct
-
The study will be conducted in the dental faculty of Hamadan Dental Students on a three-blinded basis.
-
Participants/Inclusion and exclusion criteria
-
Healthy dental students with informed consent without systemic disease, drug use, periodontal disease and pregnancy
-
Intervention groups
-
Mouth wash containing of glycyrrhiza glabra, salvia officinalis and zinc extract
-
Main outcome variables
-
Reduction of carious bacteria growth, gingival inflammation, plaque index and bleeding on probing.
General information
-
Reason for update
-
In according to other references study duration reduced from 30 day to 15 day 2 times a day.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20191225045891N1
Registration date:
2020-01-31, 1398/11/11
Registration timing:
prospective
Last update:
2020-07-11, 1399/04/21
Update count:
2
-
Registration date
-
2020-01-31, 1398/11/11
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-04-20, 1399/02/01
-
Expected recruitment end date
-
2022-04-21, 1401/02/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of glycyrrhiza glabra, salvia officinalis and zinc extract mouth wash on oral health of dental students: Clinical trial study
-
Public title
-
Glycyrrhiza glabra, salvia officinalis and zinc extract mouth wash on oral health
-
Purpose
-
Prevention
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Healthy dental students
Students with informed consent
Exclusion criteria:
Systemic disease
Drug taking
Gingival and periodontal disease
Pregnancy
-
Age
-
From 20 years old to 30 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Data analyser
-
Sample size
-
Target sample size:
200
-
Randomization (investigator's opinion)
-
Not randomized
-
Randomization description
-
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
participants, principle investigator, healthcare providers and data analyses are blinded
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-12-21, 1398/09/30
-
Ethics committee reference number
-
IR.UMSHA.REC.1398.786
Health conditions studied
1
-
Description of health condition studied
-
Gingival health
-
ICD-10 code
-
K02
-
ICD-10 code description
-
Dental caries
Primary outcomes
1
-
Description
-
Gingival health
-
Timepoint
-
Before intervention and 1 month after mouth wash using
-
Method of measurement
-
Observational
Secondary outcomes
1
-
Description
-
Plaque accumulation
-
Timepoint
-
Before and 1 month after intervention
-
Method of measurement
-
Oral disclosing tablets
Intervention groups
1
-
Description
-
Intervention group: 200 dental student voluntaryselected and divided randomly to five group each group consisting 40 student. 1. control group recieve water 2. This group receive combination of glycyrrhiza glabra, Salvia officinalis and zinc mouth washes, 3. this group receive glycyrrhiza glabra, mouth washes4. this group receive Salvia officinalis mouth washes, 5. this group receive zinc mouth washes, Two file filled for all students. one before and one 15 day after intervention. each persons used mouth washes 2 times a day for 1 minutes. Files consist: biographic data, bleeding on probing, gingival index and plaque accumulation
-
Category
-
Prevention
2
-
Description
-
Control group: Only receive water.
-
Category
-
Lifestyle
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Hamedan University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
No - There is not a plan to make this available
-
Justification/reason for indecision/not sharing IPD
-
There is no further information
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable
-
Title and more details about the data/document
-
IPD collected for the primary outcome measure only
-
When the data will become available and for how long
-
starting 6 months after publication
-
To whom data/document is available
-
people working in academic institutions
-
Under which criteria data/document could be used
-
Only for information about results
-
From where data/document is obtainable
-
fatahmadim@yahoo.com
-
What processes are involved for a request to access data/document
-
6 month after article publication and 1 month after request
-
Comments
-