Effectiveness of Fluoride Varnish in Prevention of Dental Caries in School Children

NCT02877888 | Completed Phase 1

• 1 other identifier: FRC/FDS/UOP-2014/25
• Study Type: interventional
• Target: 320
• Locations: 0 countries
• Sites: N/A

Brief Summary

Despite the availability of free health dental service in Sri Lanka, the prevalence and severity of dental caries among 6year old school children stand at a very high level according to the results of national oral health survey in 1983/84, 94/95 and 2002/2003. Professional fluoride varnish application has become popular as variety of studies has found that it is an efficient method in reducing dental caries. The simplicity of its application makes it very suitable and practical for use in dental clinics and outreach dental services, especially in young children. Aim of this study is to evaluate the cost effectiveness of 6 monthly application of sodium fluoride varnish in prevention of dental caries in permanent incisors and molars in children between 6 and 7 years in a suburban setting in Sri Lanka. This will be a double-blind, randomized controlled trial. A sample of school children (6-7 years) will be randomized into varnish and control groups. All the children will receive routine caries preventive measures of oral hygiene instructions, dietary advice and professional cleaning. Children in varnish group will receive fluoride varnish professionally applied after prophylaxis every 6 months. Clinical examinations of all children will be performed at the beginning of the study and 1 year and 2 years later. All the caries at the dentinal level of both groups will be stabilized with temporary restorations at the beginning. During this period, each school will be visited four times at 6-month interval for recruitment, dental examinations, and fluoride varnish applications. Recruited children will be randomly assigned to either a treatment (5% NaF varnish) or a control group. Caries examinations will be conducted using the International Caries Detection and Assessment System (ICDAS). The cost for the dental team's school visits; cost involved in the treatment of dental caries throughout the course of the study in both groups will be evaluated and compared at the end of the study. The sample size is calculated as 160 each arm to detect 5% caries change with 80% power. Analysis The effect of intervention will be measured by number of caries prevented. New caries in the usual care and intervention group will be calculated after the completion of the study. The costs for intervention will be estimated. The costs will be estimated for the dental material, time for human resources and indirect costs.

Conditions

Dental Caries

Keywords

cost effectiveness; fluoride varnish; dental caries

Outcome Measures

Primary Outcomes (2)

• number of caries prevented in the intervention and control gropus

  Association between sodium fluoride varnish application and the mean number of new dental caries atdifferent points are shown in table 3. Table 3: Association between sodium fluoride varnish application and new dental caries at different time points Period Mean number of dental caries in the Intervention Group Mean number of dental caries in the Control Group p value# 2015 May 0.94 1.79 \<0.001 2015 Dec 1.69 1.77 \<0.001 2016 Nov 1.50 1.97 \<0.001 #Mann-Whitney U test

  every 6 months for 2 years

• Relationship of quality of life of children with dental caries and without dental caries

  The total sample consisted of 321 students, with 161 and 162 in control and intervention groups respectively. Mean number of caries was significantly high among those who had difficulty in chewing, difficulty in vigorous chewing, difficulty in taking hot or cold food. Percentage of students with at least one dental caries at the beginning of the study was compared between different variables. If a student had at least one tooth with dental caries, was taken as positive for dental caries. Of the total population 115 (65.7%) of the students in the 6 age group had at least one tooth with dental caries and equal proportion was found among those who were more than six years as well. Difficulty in chewing (\<0.001), difficulty chewing vigorously (\<0.001), difficulty taking cold or hot food (\<0.001) and difficulty taking sweets (0.034) were experienced more by the students who had at least one dental caries.

  at the beginning of study after examination

Secondary Outcomes (1)

• Independent association between vanish intervention and new dental caries

  every 6 months for 2 years

Study Arms (2)

drug fluoride varnish /strength 22600ppm

EXPERIMENTAL

intervention: drug :fluoride varnish 22600ppm topical application every 6 months for a total period of 2 years

Drug: fluoride varnish 22600ppm

placebo comparator

NO INTERVENTION

placebo:use of routine dental advice

Interventions

fluoride varnish 22600ppm DRUG

topical application on teeth every 6months

Also known as: 5% duraphat

drug fluoride varnish /strength 22600ppm

Eligibility Criteria

• Age: 6 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children with at least one permanent tooth present.
• Age 6 to 7 years. Children under 6 years of age may be enrolled in the study if at least one permanent tooth has erupted.
• Residing in Kurunegala municipal council region and tap water is consumed (fluoride levels in drinking water is normal).
• Parental consent must be provided. If the parent is not the primary caregiver, a legal guardian or a family member who is the primary care provider must sign the consent form.

You may not qualify if:

• Children with ulcerative gingivitis and stomatitis. (These children will be referred for treatment.)
• No permanent teeth present or stainless steel crowns only.

Sponsors & Collaborators

• University of Peradeniya: lead
• Queensland University of Technology: collaborator

Related Publications (15)

• American Academy on Pediatric Dentistry; American Academy of Pediatrics. Policy on early childhood caries (ECC): classifications, consequences, and preventive strategies. Pediatr Dent. 2008-2009;30(7 Suppl):40-3. No abstract available.

  PMID: 19216381 BACKGROUND

• Gugwad SC, Shah P, Lodaya R, Bhat C, Tandon P, Choudhari S, Patil S. Caries prevention effect of intensive application of sodium fluoride varnish in molars in children between age 6 and 7 years. J Contemp Dent Pract. 2011 Nov 1;12(6):408-13. doi: 10.5005/jp-journals-10024-1068.

  PMID: 22269229 BACKGROUND

• Liu BY, Lo EC, Chu CH, Lin HC. Randomized trial on fluorides and sealants for fissure caries prevention. J Dent Res. 2012 Aug;91(8):753-8. doi: 10.1177/0022034512452278. Epub 2012 Jun 26.

  PMID: 22736448 BACKGROUND

• Chu CH, Lo E. Uses of sodium fluoride varnish in dental practice. Ann R Australas Coll Dent Surg. 2008 Jun;19:58-61.

  PMID: 19728633 BACKGROUND

• Tickle M, Milsom KM, Donaldson M, Killough S, O'Neill C, Crealey G, Sutton M, Noble S, Greer M, Worthington HV. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services. BMC Oral Health. 2011 Oct 10;11:27. doi: 10.1186/1472-6831-11-27.

  PMID: 21985746 BACKGROUND

• Lewis CW, Johnston BD, Linsenmeyar KA, Williams A, Mouradian W. Preventive dental care for children in the United States: a national perspective. Pediatrics. 2007 Mar;119(3):e544-53. doi: 10.1542/peds.2006-1958.

  PMID: 17332174 BACKGROUND

• Greig V, Conway DI. Fluoride varnish was effective at reducing caries on high caries risk school children in rural Brazil. Evid Based Dent. 2012;13(3):78-9. doi: 10.1038/sj.ebd.6400874.

  PMID: 23059920 BACKGROUND

• Bali RK, Mathur VB, Talwar PP, Chanana HB. National Oral Health Survey and Fluoride Mapping, 2002-2003, India. Delhi: Dental Council of India; 2004

  BACKGROUND

• Child Dental Health Survey 2013: England, Wales and Nothern Ireland 2013

  BACKGROUND

• State Oral Health Surveys. Centers for Disease Control and Prevention 2018

  BACKGROUND

• Chu CH, Lo EC. A review of sodium fluoride varnish. Gen Dent. 2006 Jul-Aug;54(4):247-53.

  PMID: 16903196 RESULT

• Dimitropoulos Y, Holden A, Gwynne K, Irving M, Binge N, Blinkhorn A. An assessment of strategies to control dental caries in Aboriginal children living in rural and remote communities in New South Wales, Australia. BMC Oral Health. 2018 Oct 29;18(1):177. doi: 10.1186/s12903-018-0643-y.

  PMID: 30373592 RESULT

• James P, Parnell C, Whelton H. The caries-preventive effect of chlorhexidine varnish in children and adolescents: a systematic review. Caries Res. 2010;44(4):333-40. doi: 10.1159/000315346. Epub 2010 Jul 7.

  PMID: 20606432 RESULT

• Moberg Skold U, Petersson LG, Lith A, Birkhed D. Effect of school-based fluoride varnish programmes on approximal caries in adolescents from different caries risk areas. Caries Res. 2005 Jul-Aug;39(4):273-9. doi: 10.1159/000084833.

  PMID: 15942186 RESULT

• Neidell M, Shearer B, Lamster IB. Cost-Effectiveness Analysis of Dental Sealants versus Fluoride Varnish in a School-Based Setting. Caries Res. 2016;50 Suppl 1:78-82. doi: 10.1159/000439091. Epub 2016 Apr 22.

  PMID: 27100884 RESULT

MeSH Terms

Conditions

Dental Caries

Interventions

sodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior lecturer

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: October 30, 2018
• Study Completion: November 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12