determine the effect of silver diamine fluoride(SDF) on active proximal caries lesions of primary molar teeth
Design
A randomized clinical trial with a split-mouth design, have a control group, double-blind
Settings and conduct
This study include 100 interproximal carious lesions in 50 patients treat with SDF and varnish fluoride in private pediatric office.
48 hours before the interventions, elastic separators are used to create sufficient access in the proximal areas. Bitewing radiographs and ICCMS™ radiographic scoring criteria and ICDAS scoring criteria are used to assess caries depth in primary teeth at baseline and then at 6-month follow-up. If the comparison of the baseline and 6-month follow-up, show lack of progression, that means caries are considered stopped, otherwise considered advanced and the tooth must be repaired. The researcher and the patient are blinded to the study groups.
Participants/Inclusion and exclusion criteria
Children 3 to 6 years old with at least one untreated proximal caries lesion on the first or second deciduous molars in every side of jaw
Based on clinical examinations and bitewing radiographs, the caries is limited to the outer third of the dentin
Exit criteria: distinctive systemic disease, Reluctance of the child or parents, Sensitivity to silver or other heavy metal ions, Existence of gingival ulcers or lesions around the mouth, Evidence of pulp involvement
Intervention groups
SDF: After isolation, 30% SDF is applied to the area with a fine microbrush and remains in place for 3 minutes. additions are then cleaned.
Fluoride varnish: After isolation, 5% sodium fluoride is applied to all surfaces of the target tooth.
Main outcome variables
arrest decay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220425054647N1
Registration date:2022-09-24, 1401/07/02
Registration timing:registered_while_recruiting
Last update:2022-09-24, 1401/07/02
Update count:0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Afsoon Motallebi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3225 9729
Email address
motalebia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of silver diamine fluoride with fluoride varnish in arresting proximal caries of deciduous molars
Public title
effect of silver diamine fluoride in arresting proximal caries of deciduous molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
children have at least one untreated proximal caries lesion on the first or second deciduous molars in every side of jaw(split mouth)
Based on clinical examinations and bite-wing radiographs, caries is limited to external one-third of the dentin.
children between 3 to 6 years old
Exclusion criteria:
Children with systemic diseases
Children who themselves or their parents do not want to intervene
Sensitivity to silver or other heavy metal ions
Existence of gingival ulcers or lesions around the mouth
Evidence of pulp involvement (radiographic evidence or clinical signs such as abscess)
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
2
100 teeth, from 50 healthy children aged 3 to 6 years with at least one untreated proximal caries of first or second mandibular molars on each side
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
two envelope with number 1 and 2 are prepared and every participant choose one envelope randomly
number 1 (SDF on the right tooth and varnish flouride on the loft)
number 2 ( varnish flouride on the right tooth and SDF on the left)
Blinding (investigator's opinion)
Double blinded
Blinding description
Both intervention groups are performed on one person (split mouth) who is not aware of difference of the intervention group. Clinical examinations and radiographs are performed by one of the researchers who is blind to the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, the design will be split-mouth
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of North Khorasan University of Medical Sciences
Street address
bojnourd dental university
City
bojnourd
Province
North Khorasan
Postal code
9417694735
Approval date
2022-08-28, 1401/06/06
Ethics committee reference number
IR.NKUMS.REC.1401.040
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02.6
ICD-10 code description
Dental caries on smooth surface
Primary outcomes
1
Description
tooth decay score based on ICDAS and ICCMS indices
Timepoint
Indices code at the beginning of the study and 6 months later
Method of measurement
Clinical and radiographic examination based on indices: International Caries Detection and Assessment System (ICDAS) و The International Caries Classification and Management System (ICCMS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: applying one drop of 30% silver diamine fluoride (Biodinamica, Brazil) with fine microbrush on the targeted surface area and waiting for 3 minute then clear excess
Category
Prevention
2
Description
Control group: applying 5% sodium fuoride varnish (Centrix, America) with fine brush on the targeted surface area.