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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607713053712 Date of Registration: 24/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing effectiveness of methods of providing oral hygiene information to parents for improved practices and children's oral hygiene
Official scientific title Assessing effectiveness of methods of providing information to parents on children’s oral Hygiene - Randomized Control Field Trial in Ubungo, Tanzania
Brief summary describing the background and objectives of the trial Background: Oral diseases account for 28% of children aged 4 to 12 years worldwide, and 48% are in developing countries. Although parents and guardians play a vital role in children’s oral hygiene, they have very little knowledge concerning children's oral health and consider it unimportant. Most of them are not implementing dentistry recommended practices to children under 6 years of age. As a result, poor oral hygiene practices were associated with poorer dental outcomes in East Africa sub-region. This study will examine effectiveness of mobile phone short messages and leaflets in increasing mother’s oral health hygiene awareness, improving practices, and reducing dental plaque among children aged 4 – 6 years at Ubungo, Dar es Salaam.
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 Education /Training
Anticipated trial start date 20/09/2021
Actual trial start date 11/10/2021
Anticipated date of last follow up 20/12/2021
Actual Last follow-up date 08/12/2021
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 132
Recruitment status Completed
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Leaflet Dose: Once Two weeks (14 days) Parents/caregivers were provided with leaflet containing oral health educational materials on Oral hygiene for preschool children in brief clarification and picture 40
Experimental Group Phone Short Text Message Dose: Daily messages Two weeks (14 days) Parents/caregivers received oral hygiene information through mobile phone short message to remind parents to brush their children at night before going to bed by using fluoride toothpaste. 40
Control Group Controls NA NA None. Continue with standard of care 52 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The inclusion criteria are as follows: Children with the ability to comprehend and follow instructions Parents of children aged 4 – 6 years consenting to participate in the study Reassurance to stay in the study area for the study duration  Parents/guardians without mobile  Unable to provide an alternative contact mobile number  Children living without their parents Child: 6 Year-12 Year,Preschool Child: 2 Year-5 Year 4 Year(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 02/09/2021 Muhimbili University of Health and Allied Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Upanga Magharib Dar es Salaam 11102 Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome parents/caregivers’ awareness and practices of oral hygiene practices related to oral health of their children Six weeks post-intervention
Secondary Outcome Dental plaque score in children Six weeks post-intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
School of dentistry Muhimbili University of Health and Allied Sciences Upanga Magharib Dar es Salaam 11102 Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Ministry of Health Directorate of Training Mji wa Serikali kwenye eneo la Mtumba Dodoma United Republic of Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Muhimbili University of Health and Allied Sciences Upanga Magharib Dar es Salaam 11102 United Republic of Tanzania University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Safaa Mohamed Chunga safaachunga14@gmail.com 255688404367 Ubungo
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Clinical specialist in paediatric dentistry Ubungo Municipal Council
Role Name Email Phone Street address
Public Enquiries Hawa Shariff Mbawalla hawa.homera@gmail.com 255762361537 Upanga Maghab
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Senior Lecturer in paediatric Dentistry Muhimbili University of Health and Allied Sciences
Role Name Email Phone Street address
Scientific Enquiries Hawa Shariff Mbawalla hawa.homera@gmail.com 255762361537 Upanga Magharib United Nations Road
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Senior Lecturer in paediatric dentistry Muhimbili University of Health and Allied Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data will be available via the MUHAS institutional repository or upon reasonable request to the corresponding author. Study Protocol Anonymized individual participant data underlying the published results will be shared beginning 6 months after publication and for 5 years thereafter. Access will be granted to qualified researchers with approved proposals under a formal data access agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 03/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 03/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/07/2026 Addressing the reviewer concerns ASSESSING EFFECTIVENESS OF METHODS OF PROVIDING INFORMATION TO PARENTS ON CHILDREN’S ORAL HYGIENE - RANDOMISED CONTROL FIELD TRIAL IN UBUNGO, TANZANIA Assessing effectiveness of methods of providing information to parents on children’s oral Hygiene - Randomized Control Field Trial in Ubungo, Tanzania
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/07/2026 Recommended by reviewer Experimental Group, The Leaflet arm, Dose: Once, Two weeks (14 days), Parents/caregivers were provided with leaflet containing oral health educational materials on Oral hygiene for preschool children in brief clarification and picture, 40, Experimental Group, The Leaflet allocation, Dose: Once, Two weeks (14 days), Parents/caregivers were provided with leaflet containing oral health educational materials on Oral hygiene for preschool children in brief clarification and picture, 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2026 Recommended by reviewer Experimental Group, The Leaflet allocation, Dose: Once, Two weeks (14 days), Parents/caregivers were provided with leaflet containing oral health educational materials on Oral hygiene for preschool children in brief clarification and picture, 40, Experimental Group, Leaflet , Dose: Once, Two weeks (14 days), Parents/caregivers were provided with leaflet containing oral health educational materials on Oral hygiene for preschool children in brief clarification and picture, 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/07/2026 Recommended by the reviewer Experimental Group, The Phone Short Text Message Group, Dose: Daily messages, Two weeks (14 days), Parents/caregivers received oral hygiene information through mobile phone short message to remind parents to brush their children at night before going to bed by using fluoride toothpaste., 40, Experimental Group, The Phone Short Text Message allocation, Dose: Daily messages, Two weeks (14 days), Parents/caregivers received oral hygiene information through mobile phone short message to remind parents to brush their children at night before going to bed by using fluoride toothpaste., 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2026 Recommended by the reviewer Experimental Group, The Phone Short Text Message allocation, Dose: Daily messages, Two weeks (14 days), Parents/caregivers received oral hygiene information through mobile phone short message to remind parents to brush their children at night before going to bed by using fluoride toothpaste., 40, Experimental Group, Phone Short Text Message , Dose: Daily messages, Two weeks (14 days), Parents/caregivers received oral hygiene information through mobile phone short message to remind parents to brush their children at night before going to bed by using fluoride toothpaste., 40,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 12/07/2026 Recommendation by the reviewer Control Group, The controls, Once, Once, Parents and children were given standard oral hygiene through face to face presentation and demonstration at the start of the project and left to continue with their standard of care. Letter after completion of the trial the leaflets were provided to their parents in addition,, 52, Active-Treatment of Control Group Control Group, The controls, NA, NA, None. Continue with standard of care, 52, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 17/07/2026 Recommendation by the reviewer Control Group, The controls, NA, NA, None. Continue with standard of care, 52, Active-Treatment of Control Group Control Group, Controls, NA, NA, None. Continue with standard of care, 52, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 12/07/2026 Recommended by the reviewer Primary Outcome, parents/caregivers’ awareness and practices of oral hygiene practices related to oral health of their children, Six weeks Primary Outcome, parents/caregivers’ awareness and practices of oral hygiene practices related to oral health of their children, Six weeks post-intervention
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 12/07/2026 Recommended by the reviewer -for clarity Secondary Outcome, Dental plaque score in children , Six weeks Secondary Outcome, Dental plaque score in children , Six weeks post-intervention