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The effectiveness of fluoride varnish versus pit and fissure sealant for the prevention of caries in children of primary health care

Comparison of the effectiveness of fluoride varnish versus pit and fissure sealant for the prevention of caries in children of primary health care: randomised controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN81071356
Enrollment
386
Registered
2009-08-18
Start date
2009-05-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Occlusal caries Oral Health Caries

Interventions

The choice of material to be used as a pit and fissure sealant in this project will be based on resin, since its use in primary care and is recommended by the Ministry of Health of Chile. The seala

Sponsors

Universidad de Chile (Chile)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Children of both sexes, 6 years old on average (or already in the process of eruption of first permanent molars) 2. Socio-economic levels belonging to medium-low or low status 3. Presenting at least one of the first permanent molars compatible with the application of materials, and free of clinically detectable caries (with exposed dentine) or fillings at the time of the beginning of the study 4. Who are willing to participate in the study, confirmed that by signing the informed consent letter for parents

Exclusion criteria

Exclusion criteria: Children that need some kind of special attention, as a procedure under general anaesthesia, presence of systemic disease or neurological limitations that impede their attention by a general dentist.

Design outcomes

Primary

MeasureTime frame
Early stages of the process of occlusal caries in molars, prior to the formation of cavity with obvious dentine exposure, made on the basis of the criteria proposed by the International Caries Detection and Assessment System Coordinating Committee (ICDAS II). All outcomes measured in July 2010.

Secondary

MeasureTime frame
1. Proportion of loss for the pit and fissure sealants in a period of 1 year follow up 2. Partial and total loss of pit and fissure sealants on the occlusal surface of permanent first molars, through visual examination All outcomes measured in July 2010.

Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026