NCT01829334

Brief Summary

The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China. The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution. The specific study objectives are:

  1. 1.to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
  2. 2.to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
  3. 3.to compare the cost-effectiveness of the above four caries prevention methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
329

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2006

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2013

Completed
Last Updated

April 11, 2013

Status Verified

April 1, 2013

Enrollment Period

2.9 years

First QC Date

April 8, 2013

Last Update Submit

April 8, 2013

Conditions

Dental Caries

Keywords

dental caries

Outcome Measures

Primary Outcomes (1)

  • dental caries

    development of carious cavity after 3 years

    3 years

Study Arms (4)

Resin dental sealant

ACTIVE COMPARATOR

Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement

Other: Resin dental sealant

ART dental sealant

EXPERIMENTAL

ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement

Other: ART dental sealant

Sodium fluoride varnish

EXPERIMENTAL

Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months

Other: Sodium fluoride varnish

Silver fluoride solution

EXPERIMENTAL

Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months

Other: Silver fluoride solution

Interventions

ART dental sealantOTHER

ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement

ART dental sealant
Resin dental sealantOTHER

Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement

Resin dental sealant
Sodium fluoride varnishOTHER

Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months

Sodium fluoride varnish
Silver fluoride solutionOTHER

Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months

Silver fluoride solution

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • school children in good general health
  • has at least one pair of sound permanent first molars with deep occlusal fissures or fissures with signs of early caries

You may not qualify if:

  • children with major systemic disease or on long-term medication
  • children not cooperative and refuse dental treatments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary schools

Shenzhen, China

Location

Related Publications (1)

  • Liu BY, Xiao Y, Chu CH, Lo EC. Glass ionomer ART sealant and fluoride-releasing resin sealant in fissure caries prevention--results from a randomized clinical trial. BMC Oral Health. 2014 May 19;14:54. doi: 10.1186/1472-6831-14-54.

    PMID: 24886444DERIVED

MeSH Terms

Conditions

Dental Caries

Interventions

Bifluorid 12

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Edward CM Lo

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 8, 2013

First Posted

April 11, 2013

Study Start

June 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 11, 2013

Record last verified: 2013-04

Locations

CN(1)