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.: PACTR201908699150281 Date of Registration: 29/08/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Randomized Controlled Trial on the Effectiveness of Silver Diamine Fluoride in Arresting Caries in Children in Lagos Southwest Nigeria
Official scientific title Randomized Controlled Trial on the Effectiveness of Silver Diamine Fluoride in Arresting Caries in Children in Lagos Southwest Nigeria
Brief summary describing the background and objectives of the trial Treatment of dental caries in children still remains challenging due to lack of cooperation to conventional treatment modalities. The aim of this clinical trial is to evaluate the effectiveness of Silver Diamine Fluoride (SDF) in arresting caries in children. If proven to be effective it will address some of the challenges faced in treating caries in children. The objectives of the clinical trial are: 1. To determine the effectiveness of 38% SDF in arresting caries lesion in children. 2. To compare the effectiveness of 38% SDF and Glass Ionomer Cement in arresting caries in children. 3. To assess the safety of 38% SDF as a chemotherapeutic agent in arresting dental caries in children. The study is a randomized controlled, clinical trial with 2 parallel groups. The study will be conducted in schools in Lagos, Nigeria and a total of 8 schools have been randomly selected for the study using simple balloting. A total of two hundred and fourteen (214) school children in Lagos, Nigeria aged 3-10 diagnosed of ICDAS 5 or 6 will be randomly divided into 2 equal groups using simple randomization sampling technique after informed consents have been obtained by parents. SDF will be the intervening solution for the experimental group while Glass Ionomer Cement (GIC) will be used as a standard of care for the control group. Teeth to be treated will be diagnosed for ICDAS class 5 or 6 caries. Diagnosed teeth will be cleaned and treated with SDF or GIC by the investigator. A follow up visits in 2 weeks, 1 month, 3 months and 6 months will be carried out to examine the primary treatment outcome which is arrested caries according to ICDAS criteria. Collected data will be managed and analyzed using SPSS version 23. The Pearson’s chi-square test or Fischer exert test will be used to compare the groups and test for statistical significance of the research hypothesis.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SDF GIC
Disease(s) or condition(s) being studied Oral Health
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 06/01/2020
Actual trial start date 06/01/2020
Anticipated date of last follow up 12/08/2020
Actual Last follow-up date 12/08/2020
Anticipated target sample size (number of participants) 214
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 Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Silver diamine Fluoride 2 drops once in 6 months 2 minutes The affected carious tooth with ICDAS 5 or 6 will be gently cleaned, dried and isolated with cotton rolls. Two drops of SDF solution will then be applied with a disposable microbrush on the carious tooth. The participants will not rinse for the next 10mins. Participants will also be advised to continue his or her normal oral hygiene care. The date of the treatment with the school name will be recorded in the study book to calculate subsequent time of follow up visits. 107
Control Group Glass Ionomer Cement GIC Creamy Mix 10 minutes The carious lesion of the affected carious tooth with ICDAS 5 or 6 will be excavated with disposable plastic excavator. The tooth will be cleaned, dried and isolated with cotton rolls. GIC will then be placed on the tooth cavity and allowed to flow and set. The participants will not rinse for the next 10mins. Participants will also be advised to continue his or her normal oral hygiene care. The date of the treatment with the school name will be recorded in the study book to calculate subsequent time of follow up visits. 107 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
a. Age: 3 -10 years b. Sex: Male and female c. Children with dental caries ICDAS 5 or 6. d. Children with signed consent form from parenuardians. e. Children who sign or thumb print the assent form. f. Children that will allow oral examination and application of intervention drug/placebo a. A child with symptomatic caries tooth (toothache or sensitivity). b. A child with mobile carious tooth. c. Children with dental caries ICDAS 0-4. d. A child that is allergic to silver or heavy metals e. A child with Amelogenesis or Dentinogenesis Imperfecta. f. A child with oral ulceration, stomatitis, swelling or abscess. g. A child with cooperation challenge. h. A child that is obviously mentally retarded. i. A child with systemic illness like Asthma, Epilepsis, Leukaemia, Kidney disease. j. A child whose parent or guardian cannot understand the consent documentation. Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 3 Year(s) 10 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 31/07/2019 Health Research and Ethics Committee of Lagos State University Teaching Hospital. HREC LASUTH
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Road, Ikeja, Lagos. Ikeja,Lagos 100271 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary Outcome - Arrested Caries. Secondary Outcome - Toothache, tooth sensitivity,stain, nausea, vomiting, silver allergy, oral soft tissue ulceration, rashes and any other possible dental complications. 2 weeks, 1 month, 3 months and 6 months respectively.
Secondary Outcome Toothache/Sensitivity 2 weeks, 1 month, 3 months, 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Valentina Montessori Nursery and Primary School 28 Lanre Awolokun Street, Gbagada Phase 2, Lagos, Nigeria Gbagada 100234 Nigeria
Abimbola Gibson Memorial Primary School No 1 Iyun Road, Behind National Stadium, Surulere, Lagos, Nigeria Surulere 100001 Nigeria
Ambrose Nursery and Primary School 36, Osapa Rd, Osapa-London Lekki, Lagos Nigeria Lekki 105102 Nigeria
Doseg Nursery and Primary School 21 Road, C close, House 1, Festac Town, Lagos, Nigeria Festac 102312 Nigeria
Ajao Estate Primary School 16/18 Fatai Irawo Street, Ikeja, Lagos, Nigeria Ikeja 100271 Nigeria
Tender Lilies Star Montessori School No 8 Adetayo Osho Street, Akoka, Off Fola-Agoro, Somolu, Lagos Nigeria Somolu 100242 Nigeria
Ronnie Carrie School No 2, Line A Road 2 Golden Estate, Aradagun Badagry, Lagos, Nigeria Badagry 103211 Nigeria
Redwood Academy No 3, Kayode Adebanji Street Ilamose Estate Off, Ejigbo Road, Oke-Afa, Isolo, Lagos, Nigeria Isolo 100263 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Okechukwu Moses Azuoru 58 Mufutau Ayodeji Street, Off Mobil Road, Idiroko Villa, Ajah, Lagos, Nigeria Ajah 101245 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr OKECHUKWU MOSES AZUORU 58 Mufutau Ayodeji Street,Idiroko Villa, Ajah, Lagos State. Lagos 101245 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Edomwonyi Augustine Ikponmwosa 7 Akande close off Karimu Street, Orile Iganmu, Lagos, Nigeria. Orile Iganmu 102232 Nigeria
Dr Afolabi Oyapero 1-5 Oba Akinjobi Way, GRA, Ikeja, Lagos State University College of Medicine. Ikeja 100271 Nigeria
Mr Clement Akinsola 1 -5 Oba Akinjobi Way, GRA, Ikeja. Lagos State University College of Medicine. Ikeja 100271 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator OKECHUKWU AZUORU azuoru@yahoo.com +2348033286485 58, Mufutau Ayodeji Street, Ajah, Lagos.
City Postal code Country Position/Affiliation
Lagos 101245 Nigeria Senior Registrar
Role Name Email Phone Street address
Public Enquiries Olarewaju Ojo lanreojo2002@yahoo.com +23480102327033 10 Ibadan Strret Alapere, Ketu, Lagos
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Senior Registrar
Role Name Email Phone Street address
Scientific Enquiries Funmi Ashiwaju funmash@yahoo.co.uk +2347088149350 30 Ainah Street Onipanu, Lagos.
City Postal code Country Position/Affiliation
Lagos 100271 Nigeria Senior Lecturer and Consultant Paedodontist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Interviewer administered structured Questionnaire, Record book, Images. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 2 years Phone Number +2348033286485, Email: azuoru@yahoo.com
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