Evaluating anticandidal effect of Silver Diamine Fluoride versus Chlorhexidine in children with severe early childhood caries
Design
randomized clinical parallel group trial, single blind, with control group, phase 4 on 30 patients. for generation of random allocation sequence free website of "www.randomization.com" will be used.
Settings and conduct
Tooth decay is a common problem in children. beside streptococcus mutans which is the most common cariogen, candida albicans colonies are detected in cases of early childhood caries and a number of studies showed cariogenic characteristics for these colonies. the study will be conducted in pediatric department of babol dental university. after randomization and confirming positive culture of primary samples, clean and dry tooth surfaces will be treated with silver diamine fluoride or chlorhexidine and patients will receive oral hygiene instructions. 2 and 30 days after treatment patients will be followed up and plaque samples of each step would be sent to the laboratory for colony counting.
Participants/Inclusion and exclusion criteria
Healthy children with no systemic condition, younger than 5 years old, and with severe early childhood caries and positive fungal culture of dental plaque would be entered the study.
Children who underwent either antibiotic, antifungal or fluoride therapy within the last 1 month, children with orthodontic or prosthodontic appliances or children with special health care needs and the ones with no written informed consent would be excluded from the study.
Intervention groups
There are 2 treatment groups: case group in which patients receive a single 38% Silver Diamine Fluoride Solution treatment and control group in which patient receive a single 1% Chlorhexidine gel treatment
Main outcome variables
Candida albicans colony count 2 and 30 days after the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201104049255N1
Registration date:2021-05-08, 1400/02/18
Registration timing:prospective
Last update:2021-05-08, 1400/02/18
Update count:0
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Mina Yazdizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1408
Email address
mn.yazdizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-04, 1400/03/14
Expected recruitment end date
2021-09-05, 1400/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anticandidal efficacy of Silver Diamine Fluoride and Chlorhexidine in children with severe early childhood caries
Public title
Comparison of anticandidal efficacy of Silver Diamine Fluoride and Chlorhexidine in children with severe early childhood caries
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children younger than 5 years old
Children with severe early childhood caries (according to defs scale)
Healthy children with no systemic condition
Children with positive Candida albicans culture of dental plaque
Exclusion criteria:
Children who underwent either antibiotic, antifungal or fluoride therapy (systemic or topical) within the last 1 month prior to the study
children with orthodontic or prosthodontic appliances
special health care needs children
children with no written informed consent granted
Age
To 5 years old
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
2 dental plaque samples will be collected from each patient during pretreatment and follow up phases
Randomization (investigator's opinion)
Randomized
Randomization description
The selected children were allocated into the 2 treatment groups by block randomization, through the generation of random allocation sequence using free website of "www.randomization.com", by pediatric section secretary.
Allocation concealment was achieved with numbered, opaque and sealed envelopes containing the treatment allocation cards, which were prepared before the trial.
Blinding (investigator's opinion)
Single blinded
Blinding description
Allocation concealment was achieved with numbered, opaque and sealed envelopes containing the treatment allocation cards, which were prepared before the trial. all dental plaque samples will be delivered to the lab with defined name tags (which only main researcher of the study is aware of) and there is no information about treatment group attached to the sample tubes. this way the researcher who evaluates outcome and data analyzer stay blind. according to apparent different format of study drugs (solution vs gel) and also possibility of staining of decayed teeth after fluoride therapy with SDF, blinding of main researcher or study patients would not be possible.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Dental plaque Candida albicans colony count 2 and 30 days after treatment
Timepoint
Dental plaque colony count of Candida at beginning of the study (before the intervention) and 2 and 30 days after treatment with Silver Diamine Fluoride or Chlorhexidine
Method of measurement
candida colony count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single topical treatment with 38% Silver Diamine Fluoride solution (Fagamin , Tedequim Argentina)
Category
Treatment - Drugs
2
Description
Control group: Single topical treatment with 1% Chlorhexidine gel (Corsodyl , GlaxoSmithKline U.K.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Dental Faculty
Full name of responsible person
Mina Yazdizadeh
Street address
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
Mn.yazdizadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Niloofar Jenabian
Street address
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Fax
+98 11 3229 1093
Email
www.dentpajooheshi@Yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina Yazdizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Fax
Email
Mn.yazdizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nilgoon Pasdar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Dentistry
Street address
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Email
Nilgoonpasdar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina Yazdizadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
City
Babol
Province
Mazandaran
Postal code
4717643633
Phone
+98 11 3229 1408
Fax
Email
Mn.yazdizadeh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
antifungal effects od siver diamine fluoride
all collected deidentified IPD are would be shared
When the data will become available and for how long
The data will become available 6 months after publication
To whom data/document is available
people working in businesses can also apply to receive it
Under which criteria data/document could be used
people working in businesses can apply to receive the data to update their policies in producing caries preventive materials
From where data/document is obtainable
mina yazdizadeh DDs
E-mail: mn.yazdizadeh@gmail.com
What processes are involved for a request to access data/document
one would have access to the data around 1 month after requesting via email