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Impact of Virtual Supervised Tooth Brushing Among Primary School Children in Riyadh, KSA

Primary Purpose

Dental Caries in Children

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Supervised Virtual Toothbrushing
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries in Children focused on measuring Toothbrushing, Quality of Life

Eligibility Criteria

8 Years - 9 Years (Child)All SexesAccepts Healthy Volunteers

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 form

Exclusion Criteria:

  • Children in 5th and 6th grade (11- 12-year-olds) as they would have left schools by the time of the follow-up assessment (18 months later).
  • Children who refuse to participate in the study

Sites / Locations

  • Haya AlayadiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Control group will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth.

Both groups will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child.

Outcomes

Primary Outcome Measures

Dental Caries
The study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.

Secondary Outcome Measures

Frequency of Brushing
The change in the frequency of brushing per day
Quality of Child's Daily Life
The impact of oral health on the child's daily life (QoL).

Full Information

First Posted
December 14, 2021
Last Updated
January 19, 2022
Sponsor
King's College London
Collaborators
Ministry of Health, Saudi Arabia
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1. Study Identification

Unique Protocol Identification Number
NCT05217316
Brief Title
Impact of Virtual Supervised Tooth Brushing Among Primary School Children in Riyadh, KSA
Official Title
Assess the Impact of Virtual Supervised Tooth Brushing on Dental Caries and Quality of Life Among Primary School Children in Riyadh, KSA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
Ministry of Health, Saudi Arabia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. The combination of the large burden of untreated caries among school children, low uptake of dental services when asymptomatic and the availability of free dental services makes Saudi Arabia a unique setting for school-based dental programs. Despite the availability of free dental services provided through the Ministry of Health, universities' hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when in pain. As schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.
Detailed Description
Background Dental caries is one of the most common diseases that afflict children in the Kingdom of Saudi Arabia and despite the availability of free dental services provided through the Ministry of Health, universities, hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when they are in pain thus, they reach the health care when they need complex care. Aim The aim is to assess the impact of virtual supervised toothbrushing on dental caries and quality of life among primary school children in Riyadh, KSA. Research Methodology This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). A 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months) by dental hygienist using World Health Organization criteria. Data on socio-demographic behavioral factors and children's quality of life will be collected at baseline and 12 months later through a structured questionnaire. The primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months. The secondary outcomes are the change in the frequency of brushing per day and the impact of oral health on the child's daily life (QoL). Research Significance Schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries in Children
Keywords
Toothbrushing, Quality of Life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering. Schools will be randomly selected and allocated in two groups, intervention, and control group (10 schools for each group). Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months). Both groups will receive oral assessment and both will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for each child.
Masking
Investigator
Masking Description
20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. The schools who did not respond and refused to participate will be dropped and replaced randomly from the selected list. All data entry and management will be carried out by the study principal investigator. This will be applied by pseudo-anonymization, an artificial identifier (code) will be assigned to each subject as he enrolled in the study. All the study team members will deal with coded data while collecting or analyzing information.
Allocation
Randomized
Enrollment
1280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Both groups will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child.
Intervention Type
Behavioral
Intervention Name(s)
Supervised Virtual Toothbrushing
Intervention Description
A supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child. All virtual appointments will be conducted using the collaboration of two national platforms. "Mawid", a Ministry of health (MOH) Central Appointment System, to be used by the subjects. And "ANAT" system, a Saudi Commission for Health Specialists (SCHS) application for the hygienists to use for their virtual supervision.
Primary Outcome Measure Information:
Title
Dental Caries
Description
The study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Frequency of Brushing
Description
The change in the frequency of brushing per day
Time Frame
1 year
Title
Quality of Child's Daily Life
Description
The impact of oral health on the child's daily life (QoL).
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 form Exclusion Criteria: Children in 5th and 6th grade (11- 12-year-olds) as they would have left schools by the time of the follow-up assessment (18 months later). Children who refuse to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haya Alayadi
Phone
+966551679833
Email
halayadi@ksu.edu.sa
First Name & Middle Initial & Last Name or Official Title & Degree
Areej Alsiwat
Email
aalsiwat@ksu.edu.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haya Alayadi, PhD
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haya Alayadi
City
Riyāḑ
State/Province
Riyadh
ZIP/Postal Code
12371
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haya Alayadi, PhD
Phone
+966551679833
Email
halayadi@ksu.edu.sa
First Name & Middle Initial & Last Name & Degree
Areej Alsiwat
Phone
+966503447012
Email
aalsiwat@ksu.edu.sa
First Name & Middle Initial & Last Name & Degree
Haifa A. Alakeel
First Name & Middle Initial & Last Name & Degree
Munirh Alaskar

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
This will be applied by pseudo-anonymization. A separate file all personal identifiable information for all subjects will be kept in a separate file by the principal investigator. In addition, an artificial identifier (code) will be assigned to each subject as he enrolled in the study. All the study team members will deal with coded data while collecting or analyzing information. Only the codes will be used in data entry without any identifiable personal information.
IPD Sharing Time Frame
2 years
IPD Sharing Access Criteria
Only the authorized team members will grant access to the study data.
Citations:
PubMed Identifier
14578974
Citation
Almas K, Al-Malik TM, Al-Shehri MA, Skaug N. The knowledge and practices of oral hygiene methods and attendance pattern among school teachers in Riyadh, Saudi Arabia. Saudi Med J. 2003 Oct;24(10):1087-91.
Results Reference
background
PubMed Identifier
26749526
Citation
El Bcheraoui C, Tuffaha M, Daoud F, Kravitz H, AlMazroa MA, Al Saeedi M, Memish ZA, Basulaiman M, Al Rabeeah AA, Mokdad AH. Use of dental clinics and oral hygiene practices in the Kingdom of Saudi Arabia, 2013. Int Dent J. 2016 Apr;66(2):99-104. doi: 10.1111/idj.12210. Epub 2016 Jan 7.
Results Reference
background
PubMed Identifier
15603048
Citation
Al-Yousuf M, Akerele TM, Al-Mazrou YY. Organization of the Saudi health system. East Mediterr Health J. 2002 Jul-Sep;8(4-5):645-53.
Results Reference
background
PubMed Identifier
25740856
Citation
Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
Results Reference
background
PubMed Identifier
28792274
Citation
Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
Results Reference
background
Citation
Holland WW, Stewart S. Screening in health care. Benefit or bane? London: The Nuffield Provincial Hospitals Trust; 1990.
Results Reference
background
Citation
World Health Organization. Oral health surveys: basic methods. 5th ed. Geneva: World Health Organization; 2013.
Results Reference
background

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Impact of Virtual Supervised Tooth Brushing Among Primary School Children in Riyadh, KSA

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