Toothbrushing Program in Saudi Arabia "TOPS"

NCT05512156 | Completed DMC

• 1 other identifier: 200263-41
• Study Type: interventional
• Target: 588
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Dental Caries in Children

Keywords

caries; children; prevention; toothbrushing; kindergartens

Outcome Measures

Primary Outcomes (1)

• Prevalence of Dental caries using dmft score dental inspection

  worsening of decay will be tabulated and analysed by odds-ratios, with the attendant 95% confidence interval and p-value.

  2 years

Secondary Outcomes (1)

• The numeric value of the number of excess teeth with obvious decay

  2 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

All children in the intervention arm of the study will be receiving daily supervised toothbrushing in kindergartens for two years. All children are exposed to background water fluoridation.

Other: Supervised Toothbrushing

Control Group

NO INTERVENTION

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.

Interventions

Supervised Toothbrushing OTHER

* Recruitment, consent, and Questionnaires (Behaviors, Quality of Live, Cost Analysis) distribution. * Inclusion \& Exclusion Criteria Applied * Baseline Dental examination * Toothbrushes \& Toothpastes Home and school use packs delivery-Colgate (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

Also known as: toothbrushing

Intervention Group

Eligibility Criteria

• Age: 42 Months - 66 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Child is unwell on the same day of dental inspection.

Sponsors & Collaborators

• University of Glasgow: lead
• Ministry of Health, Saudi Arabia: collaborator

Study Sites (1)

Saudi Ministry of Health

Riyadh, Saudi Arabia

Location

Related Publications (14)

• Borges HC, Garbin CA, Saliba O, Saliba NA, Moimaz SA. Socio-behavioral factors influence prevalence and severity of dental caries in children with primary dentition. Braz Oral Res. 2012 Nov-Dec;26(6):564-70. doi: 10.1590/s1806-83242012000600013.

  PMID: 23184168 BACKGROUND

• Al-Meedani LA, Al-Dlaigan YH. Prevalence of dental caries and associated social risk factors among preschool children in Riyadh, Saudi Arabia. Pak J Med Sci. 2016 Mar-Apr;32(2):452-6. doi: 10.12669/pjms.322.9439.

  PMID: 27182260 BACKGROUND

• Wyne AH. Caries prevalence, severity, and pattern in preschool children. J Contemp Dent Pract. 2008 Mar 1;9(3):24-31.

  PMID: 18335116 BACKGROUND

• Al-Malik MI, Holt RD, Bedi R. Prevalence and patterns of caries, rampant caries, and oral health in two- to five-year-old children in Saudi Arabia. J Dent Child (Chic). 2003 Sep-Dec;70(3):235-42.

  PMID: 14998208 BACKGROUND

• AlMarshad LK, Wyne AH, AlJobair AM. Early childhood caries prevalence and associated risk factors among Saudi preschool children in Riyadh. Saudi Dent J. 2021 Dec;33(8):1084-1090. doi: 10.1016/j.sdentj.2021.04.003. Epub 2021 Apr 21.

  PMID: 34938053 BACKGROUND

• Clark E, Foster Page LA, Larkins K, Leon de la Barra S, Murray Thomson W. Caries-preventive efficacy of a supervised school toothbrushing programme in Northland, New Zealand. Community Dent Health. 2019 Feb 25;36(1):9-16. doi: 10.1922/CDH_4337Clark08.

  PMID: 30667188 BACKGROUND

• Borges-Yanez SA, Castrejon-Perez RC, Camacho MEI. Effect of a School-Based Supervised Tooth Brushing Program In Mexico City: A Cluster Randomized Intervention. J Clin Pediatr Dent. 2017;41(3):204-213. doi: 10.17796/1053-4628-41.3.204.

  PMID: 28422600 BACKGROUND

• Pieper K, Winter J, Krutisch M, Volkner-Stetefeld P, Jablonski-Momeni A. Prevention in kindergartens with 500 ppm fluoride toothpaste-a randomized clinical trial. Clin Oral Investig. 2016 Jul;20(6):1159-64. doi: 10.1007/s00784-015-1604-3. Epub 2015 Sep 23.

  PMID: 26395351 BACKGROUND

• Jackson RJ, Newman HN, Smart GJ, Stokes E, Hogan JI, Brown C, Seres J. The effects of a supervised toothbrushing programme on the caries increment of primary school children, initially aged 5-6 years. Caries Res. 2005 Mar-Apr;39(2):108-15. doi: 10.1159/000083155.

  PMID: 15741722 BACKGROUND

• Andruskeviciene V, Milciuviene S, Bendoraitiene E, Saldunaite K, Vasiliauskiene I, Slabsinskiene E, Narbutaite J. Oral health status and effectiveness of caries prevention programme in kindergartens in Kaunas city (Lithuania). Oral Health Prev Dent. 2008;6(4):343-8.

  PMID: 19178101 BACKGROUND

• Curnow MM, Pine CM, Burnside G, Nicholson JA, Chesters RK, Huntington E. A randomised controlled trial of the efficacy of supervised toothbrushing in high-caries-risk children. Caries Res. 2002 Jul-Aug;36(4):294-300. doi: 10.1159/000063925.

  PMID: 12218280 BACKGROUND

• Al-Jundi SH, Hammad M, Alwaeli H. The efficacy of a school-based caries preventive program: a 4-year study. Int J Dent Hyg. 2006 Feb;4(1):30-4. doi: 10.1111/j.1601-5037.2006.00156.x.

  PMID: 16451437 BACKGROUND

• Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, Moore L, O'Cathain A, Tinati T, Wight D, Baird J. Process evaluation of complex interventions: Medical Research Council guidance. BMJ. 2015 Mar 19;350:h1258. doi: 10.1136/bmj.h1258.

  PMID: 25791983 BACKGROUND

• Almutairi B, Conway D, Ross A, Hattan M, Almogren F, McMahon AD. Toothbrushing programme in Saudi Arabia 'TOPS': a study protocol for a cluster randomised controlled trial in kindergartens, Riyadh. BMJ Open. 2024 Aug 3;14(8):e083504. doi: 10.1136/bmjopen-2023-083504.

  PMID: 39097315 DERIVED

MeSH Terms

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 23, 2022
• Study Start: September 18, 2022
• Primary Completion: September 12, 2024
• Study Completion: December 30, 2024
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)