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Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

NCT04163354 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2019-11-14

No results posted yet for this study

Summary

The current study compares the efficacy of glass ionomer fissure sealant versus topical application of 5% sodium fluoride varnish in prevention of occlusal caries among preschool children.

Conditions

  • Pit and Fissure Caries
  • Glass Ionomer Cements
  • Tooth, Deciduous
  • Child

Interventions

PROCEDURE

5% sodium fluoride varnish (NaF)

In the NaF varnish groups, 0.25mL (one drop) of the varnish is placed in a plastic dappen dish. A disposable microbrush is used to apply the varnish onto the second primary molars included in the study and all other teeth. The child is instructed not to eat or drink after the application of varnish for at least half an hour.

PROCEDURE

Glass ionomer sealant (GIS)

Glass ionomer sealants (GIS) is applied using the finger pressure technique described in the WHO manual for atraumatic restorative treatment (ART) (Frencken et al.; 1997). The primary second molars are cleaned by applying GC cavity conditioner with micro-applicator for 10-15 seconds, then clean with wet cotton pellets for several times. The surface will be dried with cotton pellets. GIS (GC Fuji VII) is mixed in standardized proportion with an amalgamator, then applied to the occlusal surface and slightly overfilled. A gloved finger with petroleum jelly will be used to push and rub the materials into the pits and fissures, and removing the excess. GIS will be covered and protected by a layer of petroleum jelly (Vaseline ®).

Sponsors & Collaborators

Principal Investigators

  • Cynthia Kar Yung Yiu, FHKAM,FCDSHK · The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-11
Primary Completion
2021-08-31
Completion
2022-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04163354 on ClinicalTrials.gov