Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202112509737803 Date of Approval: 07/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title THE EFFECTIVENESS OF SILVER DIAMINE FLUORIDE AND SODIUM FLUORIDE VANISH IN THE TREATMENT OF EARLYCHILDHOOD CARIES: A RANDOMISED CONTROLLED STUDY
Official scientific title THE EFFECTIVENESS OF SILVER DIAMINE FLUORIDE AND SODIUM FLUORIDE VANISH IN THE TREATMENT OF EARLYCHILDHOOD CARIES: A RANDOMISED CONTROLLED STUDY
Brief summary describing the background and objectives of the trial Early childhood caries (ECC) is a widespread, socio-behavioural and dental condition seen among children throughout the world.World Dental Federation (FDI) has prioritized this age group because early caries in primary teeth causes many difficulties, including problems with chewing and speaking, pain, psychological problems, and negative effects on the child’s growth, weight, and quality of life both within the family and in society. FDI promotes the use of fluoride to prevent ECC in children through health-promotion strategies and programmes. Although sodium fluoride (NaF) varnish is considered a standard of care in preventing ECC, a systematic review by the Cochrane Collaboration revealed that applying 5% NaF varnish (containing 22,600 ppm fluoride) is inadequate because it reduced only 37% of ECC development.There is a need to reduce risk factors associated ECC using inexpensive and non-invasivetreatments. Silver diamine fluoride (SDF) provides a novel, low-cost intervention option formanaging early carious lesions that could potentially bridge the ‘gap’ between non-operative and operative options; thus, postponing the first placement of a restoration and/or improvingthe quality of care for children in developing nations. Silver diamine fluoride The aim of the study is to compare the effectiveness of SDF with the traditional NaF in the treatment of ECC. Objectives 1.To determine the caries arrest rate of SDF in treating dentinal caries in children belowage 6yeras 2. To determine the caries arrest rate of 5% NaF vanish in treating dentinal caries in children below age 6 years 3. To compare the caries arrest rate of SDF and 5% NaF in treating dentinal caries in children below age 6 years 4. To determine the oral-health-related quality of life (OHRQoL) of the subjects in both groups 5. To determine the acceptability of SDF treatment by parents/caregiver
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2022
Actual trial start date
Anticipated date of last follow up 01/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group NaF group At baseline, after 1 week, after 2 weeks, after 3 months, after 6 months and after 12 months NaF varnish will be applied at three weekly intervals at baseline and at 3 months after the baseline applications and semiannual application. After the baseline visit, at each subsequent visits( 3, 6 and 12 months) No caries excavation will be performed however, gross debris will be removed using cotton isolation, lesions will be dried with air or gauze, and a microbrush will be used to apply NaF for up to 1 minute 36 Active-Treatment of Control Group
Experimental Group SDF group At baseline, after 1 week, after 2 weeks, after 3 months, after 6 months, after 12 months The SDF solution will be applied at three weekly intervals at baseline and at 3 months after the baseline applications and semiannual application. After the baseline visit, at each subsequent visits( 3, 6 and 12 months) caries excavation will be performed however, gross debris will be removed. Using cotton isolation, lesions will be dried with air or gauze, and a microbrush will be used to apply SDF or NaF for up to 1 minute 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children <6years of age 2. Healthy (medically fit) 3. Having at least 1 soft carious lesion at the dentin level tooth in a primary tooth meeting International Caries Detection and Assessment System (ICDAS) 5 criteria (i.e., dentinal caries) and without symptoms of pulpal involvement. 4. Children who are cooperative. 5. Children whose parent or guardian have given consent. 6. Children who have given their assent where possible 1. Teeth with signs suggesting non-vitality 2. Children allergic to silver 3. Children with hereditary dental alterations of teeth 4. Children with severe medical problems or emergent dental needs Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 6 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 05/07/2021 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Lagos University Teaching Hospital Idi-Araba Mushin Lagos Lagos 12003 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome carious lesion activity 3months, 6 months and 12 months
Secondary Outcome Oral health status 3 months, 6 months and 12 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Lagos University Teaching Hospital Idi-araba Mushin Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Building Research and Innovation in Nigeria Science supported by Fogarty International centre College of Medicine, University of Lagos Idi-Araba Mushin Lagos 12003 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Building Research and Innovation in Nigeria science supported by Fogarty International centre College of Medicine, University of Lagos Lagos 12003 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Dr Azeez Butali Department of Oral Pathology, Radiology and Medicine University of IOWA college of Dentistry IOWA United States of America
Dr Arwa Owais Department of Paediatric Dentistry, University of Iowa college of Dentistry Iowa United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olubukola Olatosi bukkyolatosi@yahoo.com +2348023275989 Lagos University Teaching Hospital staff quarters
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant paediatric dentist
Role Name Email Phone Street address
Public Enquiries Olubukola Olatosi bukkyolatosi@yahoo.com +2348023275989 Lagos University Teaching Hospital staff quarters
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant paediatric dentist
Role Name Email Phone Street address
Scientific Enquiries Olubukola Olatosi bukkyolatosi@yahoo.com +2348023275989 Lagos University Teaching Hospital staff quarters
City Postal code Country Position/Affiliation
Lagos Nigeria Consultant paediatric dentist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in the article after deidentification (tables, figures,text and appendices) will be available Study protocol will be available Data will be available to researchers who provide a methodologically sound proposal immediately after publication. No end date Proposals should be sent to bukkyolatosi@yahoo.com Study Protocol 12 months Not available yet
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information