This manuscript adheres to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement (23) for reporting of protocols for clinical trials and the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement – extension for cluster randomised trials (24).
Study Design And Setting
The trial is a cluster randomised control trial, assessor blinded running in two parallel groups with a 1:1 allocation ratio. The trial will be conducted among selected primary schools in Riyadh city, Saudi Arabia within 18 months durations. Randomisation will be at cluster level (school) to prevent any contamination probability between participants across intervention groups if located in the same school.
Setting And Participants
The trial will be conducted across 20 primary schools in Riyadh city, Saudi Arabia. A list of all governmental primary schools in Riyadh city, Saudi Arabia, will be obtained from the Ministry of Education and random selection will be conducted. Schools with in-house dental clinics and participating in any dental screening/preventive program will be excluded from the trial.
Children in selected primary schools will be considered eligible to join the trial if they meet all inclusion criteria and none of the exclusion criteria.
Inclusion Criteria
Children aged 8 to 9 years (4th grade at school) at baseline
Both Saudis and non-Saudis
Children for whom the person with parental responsibility has signed the consent/assent form
Exclusion Criteria:
Trial Interventions
Oral epidemiological assessment will be conducted in-person in the Preventive Dentistry Clinics to all children within both intervention groups. The difference between two intervention groups lies in that the intervention group will receive virtual supervision on toothbrushing once a week by the dental hygienist through "Mawid" a Ministry of health (MOH) Central Appointment System, and for four days during the week they are provided with different videos of the correct tooth brushing method. -This continues for three consecutive months-
Appointments will be booked via “Mawid” with is a (MOH) Central Appointment System and mobile application for managing appointments in primary healthcare centres and hospitals nationwide (25), while the Virtual Appointments will be conducted using “Sehhaty”; a public mobile application integrated with “Mawid” used for various health services such as sick leave, e-prescription, and managing in-person and virtual appointments nationwide (26). All virtual appointments during the study will be booked accordingly and subjects will receive SMS with the date and time of his/her appointment and a link on how to use the service (27). The Virtual Appointments will be conducted using the collaboration of two national platforms. “Sehhaty”, to be used by the subjects. And “ANAT”, to be used by the physicians. Whereas “ANAT” is a MOH Approved Platform used for virtual consultations booked in both “Mawid" and "Sehhaty" (28).
A comparison against a control with no intervention was not considered due to ethical concerns (children would be examined but not informed about their oral findings). Thus, children in both groups will be informed about their oral findings and will be educated about how to make an appointment through “Sehhaty” application, all treatment will be provided free of charge. It is worth noting that both groups with will receive fluoride toothpaste (1450 ppm) along with the examination received. In this trial we will consider those with untreated dental caries as screened positive children were as all others will be considered as a screened negative child, based on the World Health Organization (WHO) criteria (29). At the time of examination parents or caregiver will be provided an electronic WHO questionnaire to fill (29).
Intervention group will receive virtual supervision on tooth brushing once a week by the dental hygienist through "Mawid" a Ministry of health (MOH) Central Appointment System, and for four days during the week they are provided with different videos of the correct tooth brushing method. -This continues for three consecutive months-. The only difference between intervention and control groups relay on that the control group will not receive any virtual supervision on tooth brushing.
Outcomes
The combination of self-reported and clinical outcome robust the findings on the effectiveness of virtual supervised toothbrushing. The clinical measure will be a blinded outcome measures (caries experience) as the examiners are blinded to the groups the children are assigned to. Unlike the clinical outcome, the self-reported frequency of toothbrushing per day and impact of oral health on the child’s daily life (QoL) are considered a subjective measure.
Primary Outcome
The study primary outcome is the change in caries experience -the number of decay (untreated dental caries) missing and filled teeth - in both primary and permanent teeth over 12 months as well as plaque and gingival index. The underlining assumption of the selected primary outcome is that children in the intervention group will be exposed to more fluoride (toothpaste daily exposure) in addition to mechanical tooth cleaning (correct dental plaque debridement through correct brushing technique) during the trial period leading to a fewer incidence of dental caries than those in the control group.
Secondary Outcomes
Two secondary outcomes for this trial include; the change in the frequency of toothbrushing per day and the perceived oral health on child's daily life (as reported by the parents)
Trial Procedure
The time schedule of the enrolment assessment, intervention and assessment is shown in Fig. 1.
Randomisation
A stratified random sampling technique will be performed were Schools are the unit of randomisation and stratum bill be based on the gender (the Saudi Arabia education system is a segregated campus between male and female schools). Random sampling will be used to allocate schools to either an intervention or a control group within each stratum. An external researcher will perform the allocation sequence using a computer-generated random number then inform the principle investigator (HA), who subsequently will assign the intervention team (performing virtual supervised tooth brushing) to the children in the intervention group.
Blinding
Children participating in this study cannot be blinded given the nature of the intervention. Both children and their parents will be provided an information sheet that explains the intervention thus will know whether they will be in either intervention or control group. Examiners will be blinded as children in both groups will be dealt with equally in the examination appointment. All outcome assessment data will be delivered to the principle investigators and thus each child will be identified to the allocated group according to the child's code and school code. It is worth mentioning that we chose the caries experience to be the primary outcome as clinical outcome are considered an objective finding thus more reliable and less prone to measurement bias associated with subjective self-reported measures.
Data Collection
The study will acquire approval from the Ministry of Health in Saudi Arabia to ensure no school-based dental program is implemented in the selected schools and to utilize the ministries staff and information technology facilities (Mawid, Sehhaty and ANAT applications). Also, an aapproval from the Ministry of Education will be obtained to both access schools and to obtain a list of schools in Riyadh city.
Following obtaining the approvals, the principle investigators will send an invitation to the selected schools. Schools refuse to participate or don’t replay will be replaced with randomly chosen new school from the same list obtained. Schools that agree to participate, the principle investigator will arrange a date and time for data collection through meeting with the head of the schools.
All children eligible to participate in the schools that agree to participate will receive a booklet that includes; an information sheet a written and consent form to both children and their parents. A text message from the school administration will be sent on the same day informing the parents about the booklet and encouraging them to participate. After one week, a reminder text message will be sent to parents who did not send the forms back and an acknowledgment text will be sent to those agreeing to participate.
After obtaining signed consent from both parents and their children the team will book a clinical examination appointment to the children through (Mawid). Parents will receive an SMS message confirming the appointment.
On the day of the booked clinical examination, the parents will be asked to fill structured questionnaire while their children being examined. The parental questionnaire has been modified from the WHO questionnaire for assessment of oral health status to collect data on socio-demographic characteristics (child's age and gender, school, household size, parental education and family income), data on dental visit oral hygiene perception and behaviour, oral health impact on quality of life and diet. Questionnaire will be deiminated with every follow-up clinical examination (+ 3 months, +6months + 12 months from baseline).
A total number of 40 dental hygienists will be included in this trial under the supervision of the principle investigator. Twenty dental hygienists performing the clinical examination in Ministry of Health Primary Health Care Centre, all will be trained and calibrated before the beginning of the trial. The other 20 dental hygienists will be responsible for virtual supervised tooth brushing were two dental hygienists be assigned to each school (2:1 ratio).
Clinical examination for caries experience will be performed according to the WHO criteria, that define dental caries at the caries into dentine threshold (29). No radiographs will be taken. Examination will be conducted similarly at baseline and all following follow-up (+ 3 months, +6months + 12 months from baseline). Examination will be performed in a dental clinic on dental chair using an examination kit that include plane mouth mirror and a periodontal probe. Teeth will not be brushed or cleaned prior to the examination as plaque index is one indicator of caries experience. During the examination air will be applied to better assess the plaque, this will be followed by removal of debris using gauze and cotton roll to facilitate visual inspection and assess gingival condition and dental caries. Standard infection control will be in place.
After each clinical examination phase (baseline, + 3 months, +6months + 12 months), 10% of children will be re-examined to assess inter-examiner reliability. Children with identified positive caries will be informed and parents will be instructed to book an online appointment through (Mawid). Given the training in oral health condition assessment, the probability of false positive caries cases is minimal. Yet upon the booked appointment by the parents a standard dental check-up is always conducted as part of the treatment plan where any false-positive cases will be identified. If that is the case the dentist will inform the parents that no further treatment is required.
Ensuring Participants Retention
Given that this is a 12 months trial, with different points of data collection (baseline, + 3 months, +6months + 12 months) and the final follow-up collected in separate academic year. This implies that there might be some losses in follow-ups as children may change their schools/residence. We have increased the trial size to compensate for 20% attrition rate (i.e. derived from the proportion of children continuing in the same school the following academic year). That aside, we expect a high completion rate as parental consent will be sought for all waves of data collection simultaneously.
Data Storages And Management
The principle investigator will be responsible for all data entry and management. Personal identifiable information will be collected to regain contact with the child for the follow-up assessments and link different points of data collected for the same child. This will be handled by a pseudo-anonymisation, were the principle investigator will keep a separate file that includes all personal identification information for all children participating in the trial. An artificial identifier (code) will be assigned to each child as they enter the study. Thus, all involved in the trial will be working with coded data when collecting or analysing information.
Only the codes will be used in data entry without any identifiable personal information. A protected device (university desktop) assigned for the primary investigator will be used to enter the coded data as long as the data collection progresses. Upon completion of data collection, all electronic files (consents, Assents, and questionnaires) will be transferred to a password-protected desktop computer and all printed forms (oral assessment forms) will be transferred to a locked cabinet and both located at College of Applied Medical Sciences at KSU. Only the authorized team members will grant access to the study data.
Data Analysis
Justification of sample size
Based on total number of school children in Riyadh City (30) and previous study conducted on the same target (31), a sample size of 455 children (in each trial group) is required to detect a 0.50-unit difference in the number of teeth with untreated caries between the two groups, assuming 80% statistical power, 5% significance level and intra-class correlation coefficient (ICC) for dental caries at individual level of 0.05. The total sample size will be rounded up to 1092 (546 in each group) to allow a dropout rate of up to 20%.
Between Groups Comparisons
A comparison of demographic (sex, gender), socioeconomic (family income, parental education), behavioural characteristics (toothbrushing frequency, usage of fluoride toothpaste, dental attendance pattern, impact of oral health on daily living, sugar intake) as well as caries and plaque level in both deciduous and permanent teeth and gingival condition between both intervention group will be carried out using chi-square test for categorical variables and a t test for continuous variables.
We will be reporting absolute and relative measure effect; that is, absolute and relative difference in mean for continuous outcomes (changes in the number of untreated caries) and risk difference and relative risk for categorical outcomes (changes in brushing frequency, changes in plaque and gingival conditions, changes in impact of oral health on daily living). For the primary outcome (changes in the number of untreated dental caries), negative binomial regression will be used to estimate relative difference (incidence rate ratio) and predictive margin to estimate absolute difference between intervention groups. The applied analytical technique will allow accounting for stratification of the sample and clustering of children within schools and any baseline socioeconomical difference between intervention groups. For the secondary outcome, multinomial regression will be used to estimate relative risk for the changes in frequency of daily tooth brushing and changes in the perceived oral health on child's daily life. Predictive margins will also be used to estimate absolute difference in each secondary outcome. Intention to treat analysis will be used to handle missing values in categorical outcomes. Multiple imputation will be considered an option for continuous outcomes.