Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05512156 |
| Other study ID # |
200263-41 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 18, 2022 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of Glasgow |
| Contact |
Budur Almutairi, Dr |
| Phone |
07453290260 |
| Email |
2170410a[@]student.gla.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Project summary
Introduction: Dental caries is a major oral health problem worldwide and is a particular
public health challenge in Saudi Arabia. Dental caries cause pain, infection, and negatively
impact quality of life. As part of population oral health improvement efforts in Saudi
Arabia, this project aims to evaluate the effectiveness of a supervised toothbrushing
programme in kindergartens.
Aim: The aim of this project is to conduct a trial to assess the effectiveness of a
supervised toothbrushing programme in kindergartens in Riyadh, Saudi Arabia .
Methods: A cluster randomized controlled trial study will be undertaken in which the
effectiveness of the daily supervised toothbrushing programme intervention running for two
academic years will be randomly allocated to a sample of kindergartens in Riyadh and compared
against treatment as usual which will be an annual oral health awareness visit in the control
group of kindergartens over and above community water fluoridation. Effectiveness will be
measured and delivered in terms of preventing dental caries in children when compared with
children in the treatment as usual control group receiving the same level of community water
fluoridation, but not the toothbrushing program intervention.
All children in all kindergartens (both intervention and control groups) will have a dental
examination (via trained and calibrated dental teams recording dental caries levels via dmft
index) at baseline before intervention commences and at two academic years. In addition,
questionnaires on behaviours and quality of life. In addition, process monitoring, and cost
analysis surveys will be distributed.
Research Questions:
- Can such a supervised toothbrushing programme in kindergartens be effective at reducing
the development of dental caries by 6 years of age?
- Can a supervised toothbrushing programme in kindergartens in Saudi Arabia be established
and implemented?
Description:
Background Studies confirmed caries and socio-economic factors association. Caries prevalence
in children was related to parental factors, such as parents' socio-economic status,
behaviors, and their attitudes to oral health. Several studies examined the prevalence of
dental caries and associated social risk factors among preschool children in Riyadh, Saudi
Arabia. Al-Meedani and Al-Dlaigan in 2016, found that among the total of 388 children
examined in Riyadh, 69% had dental caries. There was no statistically significant difference
between boys and girls in caries prevalence. There was a significant association between
caries prevalence and parental educational level. Children of mothers with postgraduate
degrees had higher caries prevalence of 57% while children of mothers with bachelor's degrees
and high school level or below had caries prevalence of 66% and 78% respectively. The
children of non-working parents had higher caries prevalence compared to those with working
parents. The children from larger family size had higher caries prevalence as compared to
those from smaller family size.
Another study by Wyne (2008) reported an overall caries prevalence of 74.8% among preschool
children who had a mean age of 4.7 years in Riyadh. Similarly, Al-Malik et al (2003) found
that 73% of two- to five-year-old children in Saudi Arabia were diagnosed with caries4.
Another cross-sectional study by AlMarshad et al 2021, included Saudi preschoolers aged 36-71
months where a total of 383 children were examined. Early childhood caries (ECC) prevalence
was 72.6%. Children from schools in northern Riyadh and those of fathers in professional jobs
were less likely to have ECC. Children with a nocturnal feeding history and poor oral hygiene
were more likely to have ECC.
Oral health improvement programms in education settings such as kindergartens and schools are
particularly important because they have shown to be effective and can have the potential of
a wide reach across the population during the crucial early years of childhood. Some studies
have found that a programme of supervised daily toothbrushing in school can be effective in
caries reduction particularly in high-risk populations, it can reduce caries increment in a
population experiencing high levels of dental disease. In addition, school-based supervised
toothbrushing programme can improve oral hygiene including decreasing levels of plaque,
gingival bleeding, and gingivitis. There have been fewer randomized controlled trials of
supervised toothbrushing programme particularly in areas with high caries or where other oral
health improvement program or initiatives are in place such as water fluoridation.
In a trial including 2228 two to four year-old children attending kindergartens in two
counties in northern Hesse, German were randomly allocated to participate in daily tooth
brushing with 500 ppm fluoride toothpaste, which was supervised by specially trained dental
nurses. The caries increment of the test group was 24% lower than the increment of the
control group, and high increment values were observed in the control group twice as often as
in the test group. Another trial in England recruited a total of 517 children (mean age 5.63
years) which children in the intervention group brushed once a day at school. For children in
the intervention group, the overall caries increment (2.60) was significantly less than for
children in the non-intervention group (2.92). In Kaunas city of Lithuania a sample of 411
three years old children were selected to participate in the prevention programme. For test
group, supervised toothbrushing was prescribed, and for the control group, children did not
undergo any of the procedures. The prevalence of dental caries varied between 39.7% and
90.8%, the reduction in test group was 45.4%. In another clinical trial in Tayside, that was
to determine the reduction in two-year caries increment that can be achieved by daily
supervised toothbrushing on schooldays, combined with recommended daily home use, compared to
a control group involving no intervention. A sample of 534 children, mean age 5.3, in schools
in deprived areas were recruited and significant reductions of 32% at D (1) and 56% at D (3)
were found. In a study in Jordan, has a similar cultural and community background to Saudi
Arabia, caries status of children in the supervised daily tooth brushing group over four
years was better than that of the control group. The difference was statistically significant
with estimates of relative risk values also showed that children in the control group are 3.1
and 6.4 times at higher risk of having dental caries than those in the study group for age
group 12 and six respectively .
Although, there were no enough studies undertaken in background of water fluoridation or in
the Saudi population, many international good studies for long follow-up periods had
recommended to apply the supervised toothbrushing programme especially in communities with a
high prevalence of caries, such as the Saudi community.
Study rationale - hypothesis In kindergartens schools in Saudi Arabia - the main setting for
this trial - despite the extremely high levels of dental caries among young children
attending, there has been no oral health improvement program established to date.
This trial will assess whether a supervised toothbrushing program can be established and
implemented and what the barriers and facilitators to roll out would be. It also aims to
deliver direct benefits to the trial population by reducing caries prevalence. The null
hypothesis is therefore that the caries levels of children in the supervised toothbrushing
arm of the trial after two academic years of the intervention will be no different to that of
the children in the control arm. The intervention is also taking place in areas where there
has been community water fluoridation since 2007.
Study objectives The objective of this study is to compare the effectiveness of supervised
toothbrushing with treatment as usual in preventing any further dental decay from developing.
Methods/Design Basic Design: Cluster randomized of tooth-brushing in kindergartens in Riyadh
KSA Group 1 - Toothbrushing. Group 2 - Leaflet. Definition of endpoints and covariates The
main outcome measurement will be the number of teeth with obvious decay experience into the
dentine for a participating child. This will be measured at both the baseline visit and after
two years of follow up. The difference from two years minus the baseline measure will then be
calculated. Any negative differences will be set to zero. Negative differences can happen
either due to tooth trauma or due to variations in the inspection data (which is to be
expected due to the nature of tooth charting, and this is especially possible when different
dentists/therapists inspect the same child). The primary endpoint will be 'worsening of
decay', namely an increase in the number of decayed teeth of one or more. This variable can
be coded as a binary variable with categories of Yes and No. The secondary endpoint will be
the increase in the number of teeth affected. The study will recruit from both public and
private kindergartens. A priori subgroups of region, school type and the sex of the child
will be considered. A further subgroup of existing decay at baseline (Yes/No) will be
considered.
Study population One hundred fifty-three children will be recruited into each of the two arms
of the study. They will be identified in 20 kindergartens public and private schools in the
Riyadh city, North and East areas. The sample is four years old attending participating
kindergartens schools. Children approval to participate will be assessed by consent forms
that will be send to parents and schools prior to study entry.
Inclusion criteria
- Receipt of a signed informed consent form from a parent or legal guardian.
- Children in the second year of kindergarten school (known as KG2).
- Children with or without pre-existing dental caries.
Exclusion criteria
_ Child is unwell on the same day of dental inspection.
Identification of participants and consent Once the head teacher has given permission, a
consent form will be given or sent to the parents or guardians of every KG2 child. Informed
consent will be obtained directly by members of the study team at their child' s kindergarten
or advance consent arranged by the headteacher. On the day of the dental inspection any child
showing distress or verbal, or non-verbal signs of extreme reluctance will be excluded from
the study if the dentists feel that continuing with the inspection would cause the child
further distress.
Study schedule Up to three visits are involved for children who are retained throughout the
study. The first will be to complete the baseline dental inspection and baseline
questionnaires distribution. The second visit is after one year of intervention for follow
up, toothbrushing packs and behavioral questionnaires distribution. The final visit is to
undertake an endpoint dental inspection to reinspect the child in year three of their
kindergarten school and endpoint questionnaires distribution. Neither children nor parents
are required to make special visits to a clinic or other study base.
Visit 1: Examination /0-month intervention visit(s) At this visit study staff will confirm
eligibility before the baseline dental examination is carried out by a study dental
practitioner (e.g., signed consent form is in place, and the child has no obvious temporary
infections or injuries which would lead to exclusion on the day). Completion of dental
examination data and then packages of toothbrushes will be distributed, and supervised
toothbrushing will be explained to both teachers and children follow to Childsmile
guidelines.
Visit 2: One academic year (+/- 3 months) Questionnaires and toothbrushing packs
distribution.
Visit 3: Two academic years (+/- 3 months) Endpoint Questionaries' distribution and
end-of-study dental examination visit.
This visit will be conducted when participating children are in KG3, and and approximately
five to six years old. The final dental examination will be carried out, regardless of
whether the sequence of the supervised toothbrushing had been interrupted or discontinued for
any reason.
Study outcome measures The main outcome measurement will be the number of teeth with obvious
decay experienced into dentine for a participating child. This will be measured at both the
baseline visit and after two academic years of follow-up. The difference from two academic
years minus the baseline measure will then be calculated. Any negative differences will be
set to zero. Negative differences can happen either due to tooth trauma or due to variations
in the inspection data. This is to be expected due to the nature of tooth charting, and this
is especially possible when different dentists/therapists inspect the same child.
The primary endpoint will be 'worsening of decay', namely an increase in the number of
decayed, missing, or filled teeth of one or more. This variable can be coded as a binary
variable with categories of Yes and No. The secondary endpoint will be the increase in the
number of teeth affected.
Sample size The sample size calculation is based on the primary endpoint of decay worsening.
This calculation has used a power of 80% and an alpha level of 5%. As this is a cluster
randomized trial the usual sample size is slightly inflated by the design effect (DE) of DE =
1 + (N - 1) *ICC. N is the average class size, which assumed to be 15 children being
successfully inspected. Partly based on pilot data and partly based on the traditionally weak
intra-class correlations (ICC) in public health that have been assumed to be 0.001, which
produces a DE of 1.019. To detect a difference of 15% worsening in the toothbrushing group
versus 30% in the leaflet group,122 children in each group with evaluable endpoints will be
required, providing a total sample size of 244 children. Note that to contribute an evaluable
endpoint a child will need valid dental inspections at both the baseline and the end of the
study. However, in practice not all the children will complete the study. If a loss to
follow-up rate of 20% assumed, inflation of the number of children are required to be
randomized to153 in each group, and 306 children in total. This corresponds to approximately
20 schools.
In summary:
- randomize 153+153 = 306, from 10+10 schools,
- the sample size requires 122+122 = 244 evaluable endpoints.
Withdrawal of subjects Parents who withdraw their child will be asked, if appropriate, to
agree to their having the end-of-study dental examination, to make best use of the
information that has been collected on that child. Children who leave a trial kindergarten
school during the study, but remain in the local area, and go on to attend a local school
will receive an endpoint dental inspection. The parents/guardians of these children will be
informed of the inspection. Any adverse reactions to the fluoride (e.g., mucositis, allergic
reaction etc.), whether noted by dental staff or reported by parents or school, will be
entered into the Case Report Form by the study team. All recorded adverse reactions will be
reviewed and if any immediate adverse reaction is suspected, the toothpaste can be easily
removed by toothbrushing, rinsing and spitting. In the event of a child having to leave the
study due to withdrawn consent, or moving home and so on, the head teacher at the school will
inform the study team. If the parent agrees, arrangements will be made to complete the
end-of-study dental inspection to maintain that child in the study database (End of Study
Form completed).
Statistics and data analysis The primary endpoint of Worsening Decay will be tabulated and
analyzed by odds-ratios, with the attendant 95% confidence interval and p-value. This will
also be carried out for the three subgroups separately. Additionally, interaction tests will
look at any possible synergy or antagonism of the treatment effect with the three subgroups
(separately). Logistic regression models will be used for these analyses. The numeric value
of the number of excess teeth with obvious decay (i.e., the secondary endpoint) will also be
analyzed. All statistical tests will be carried out at the traditional 5% significance level,
using the software package SAS version 9.4. There are no issues with multiple testing as the
primary endpoint and analysis are clearly defined, with the other analyses being of an
exploratory nature.
Questionnaires In addition to clinical data, information on how a child's general and oral
health affect their quality of life will be collected using a Child Health Utility 9D
questionaries' which will be distributed at three points in the trial: at baseline,12 months
and endpoint .Also, parents/guardians of participants will be asked to complete behavioural
questionnaire on how is the health of child teeth, how they take care of them and the child
diet, in baseline,12months and endpoint intervals(APPENDIX 8) and, a questionnaire on health
and dental care services resource use (APPENDIX 9) designed to elicit information on uptake
of health and dental care services and medication use by the child within the past 12 months
will also be at each of the baseline and endpoint rounds. The questionnaire packs will be
distributed to the families via the kindergarten. Follow-up procedures parental questionnaire
survey, several well-established techniques to enhance response rates will be used.
These are:
- the cover page for the questionnaire pack sent at baseline.
- parents who had previously provided a mobile telephone number will receive a text
reminder if they have not returned the questionnaires within one week.
- at the end of the second week a second copy of the questionnaire pack will be mailed to
any non-responders directly to their home address or distributed via the child's
kindergarten.
- at the end of the third week the non-responder parent will be contacted by telephone to
remind them to complete the questionnaires.
In addition, information on school health policies about School Health Services, school
physical environment, School Health Services, health education, school policies and Resources
will be collected through headteachers surveys(APPENDIX 10).
Intervention Costs Staff travel costs that are related to staff delivering the interventions
will be collected. Members of staff will be asked to fill in a "staff travel cost" form each
time they visit a kindergarten. A full economic evaluation of the study will be carried out
and will be reported separately following the UK's National Institute for Health and Care
Excellence (NICE) public health economic evaluation guidelines, [NICE, 2012]. Health outcomes
will be expressed over the two academic years follow-up period using the Child Health Utility
9 Dimensions questionnaire to obtain utility scores.
Intervention Group
- Recruitment, consent, and Questionnaires (Behaviours, Quality of Live, Cost Analysis)
distribution.
- Inclusion & Exclusion Criteria Applied
- Baseline Dental examination
- Toothbrushes & Toothpastes packs delivery (six pack per child a year- child soft
toothbrush with a1450ppm fluoridated toothpaste))
- Supervised teachers training
- Three months intervals monitoring visits
- "12months" Follow up and Questionnaires (Behaviours) distribution
- Endpoint dental Examination and Questionnaires (Behaviours, Quality of Live, Cost
Analysis) distribution
Dry Toothbrushing
- The supervisor should wash their hands with soap and warm water, and thoroughly dry
them, before and after the toothbrushing session to prevent cross-infection.
- The child (under supervision) is responsible for collecting the toothbrush from the
storage system. Adaptations should be considered if a child has additional support
needs.
- Toothpaste is dispensed following the appropriate methods
- Toothpaste provided by the program, containing 1,450 ppm (parts per million) fluoride,
is used.
- A pea-sized amount for children three years and over.
- Where toothpaste is shared, a supervisor dispenses it onto a clean surface such as a
plate or paper towel.
- There is sufficient spacing between the quantities of dispensed toothpaste to allow
collection without cross-contamination.
- Toothpaste must only be dispensed at the time the child is ready to brush.
- Supervisors should cover any cuts, abrasions or breaks in their skin with a waterproof
dressing.
- Children may be seated or standing while toothbrushing takes place.
- After toothbrushing is completed, children should spit excess toothpaste into either a
disposable tissue, disposable paper towel or disposable cup.
- Tissues/paper towels or cups must be disposed of immediately after use in a bin.
- Toothbrushes can either be returned to the storage system by each child. The system is
then taken to an identified sink area by the supervisor, who is responsible for rinsing
each toothbrush individually under cold running water or rinsed at a designated sink
area where each child is responsible for rinsing their own toothbrush under cold running
water. The supervisor or the child can be responsible for the control of the running
tap.
- After rinsing of the toothbrushes is complete, the child or the supervisor is
responsible for shaking off excess water into the sink. Toothbrushes should not come
into contact with the sink.
- Each child (under supervision) is responsible for returning their own toothbrush to the
storage system to air dry. Adaptations should be considered if a child has additional
support needs. Lids should be replaced at this stage if there is sufficient air
circulation.
- Paper towels should be used to mop up all visible drips on the storage system.
- Children should be supervised. It can be done by lines or sitting on their chairs to be
better controlled.
- Supervisors are responsible for cleaning sinks with disinfectant after toothbrushing is
completed.
Control Group:
All children in the control arm of the study will be receiving TAU which is awareness
sessions in the school about importance of the daily brushing, healthy diet and demonstrating
how to brush correctly and efficiently. All children are exposed to background water
fluoridation.
Study Monitoring Study Monitoring Visits will be conducted by the Saudi Ministry of Health
(MOH) dental staff team every three months with toothbrushing packet distribution. A
monitoring sheet will be used by the monitor and the supervised teacher. A single named
person at each treatment site, responsible for overseeing the intervention, will be asked on
each quarterly visit whether children have the opportunity to brush their teeth every day,
and if not to explain when/why this may not be possible. They will then be asked to give the
main challenges to daily brushing (barriers) and to say what helps.
Process evaluation
Research team will conduct an integrated process evaluation of the trial, which will allow us
to:
- Describe the implementation of the intervention and data collection in schools,
including barriers and facilitators to efficiency and effectiveness
- Collate experiences of those involved, including staff and parents
- Make recommendations for full roll-out of the program in Saudi Arabia, should the trial
be successful
- Make recommendations for the carrying out of trials in early years settings, and for
complex community-based trials in general
Monitoring visits Process visits to treatment sites will take place quarterly (every three
months) throughout the trial. These will be carried out by the MOH dental team staff and will
coincide with delivery/ distribution of trial materials (toothbrushing packs) for efficiency
of cost.
A single named person at each treatment site, responsible for overseeing the intervention,
will be asked on each quarterly visit whether children have the opportunity to brush their
teeth every day, and if no to explain when/why this may not be possible. They will then be
asked to give main challenges to daily brushing (barriers) and to say what helps
(facilitators; see Appendix 11, part B, the dedicated pro-forma to assess uptake/fidelity of
the intervention).
Context surveys As well as quarterly monitoring visits, a dedicated survey of school health
policies and practices will be carried out. This survey will be administered to Head Teachers
(or other suitable education leads) at both treatment and control schools. This covers any
ongoing contextual activity that could affect the children's oral health such as hygiene
provision, nutritional services and policies, health education and resources etc.
The process evaluation is guided by a simple logic model for the trial which sets out
intended resource use, key activities and intended short and longer-term outcomes.
Training and calibration course The training and calibration course for the Detailed dmft
survey of KG2 children in Riyadh will be organized and held by Dental Health
Department-Health at MOH in Sep,2022. The training and calibration protocol and materials
follows the Scottish National Dental Inspection program resources NDIP. Mandatory training
and calibration will run three inspection teams (three dentists and three dental assistants).
Training involves sessions on inspection procedures, tooth codes and diagnostic criteria
based on the British Association for the Study of Community Dentistry (BASCD) Trainers'
Pack5. Clinical training sessions will then undertake on schoolchildren and will be followed
by the calibration sessions on a further group of KG2 children. Calibration sessions involve
each inspection team examining the same children. The number of children on each course range
from 11 to 12. Analyses will be then undertaken by the Community Oral Health research group,
University of Glasgow Dental School. Inter-examiner agreement will then be assessed using the
percentage agreement and Kappa statistic assessed at the tooth level on dmft components.
Ethical considerations This study was approved ethically by the King Fahad Medical City
institutional review board in the Saudi Ministry of Health (22-083E/March 2022). Study
participants will only be allowed to enter the study once either a parent or legal guardian
has provided written informed consent. The Chief Investigator will be responsible for
updating the Ethics Committee on any latest information that is related to the study. The
data analysis for this study had been approved ethically by the University of Glasgow
Medicine, Veterinary, and Life Sciences Research Ethical Committee (200220194/March 2023).
Informed consent Written informed consent will be obtained from a parent or legal guardian,
as applicable, of each trial participant. When a study team member present at the
kindergarten will explain the exact nature of the study, answer any questions, and address
any concerns. Trial participants will be informed that they are free to withdraw their
consent from the study at any time.
Dissemination of findings Study team members will collaborate on producing papers to be
submitted to peer-reviewed journals and abstracts of proposed presentations at national and
international conferences and symposia.
