NCT04163354

Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

Glass Ionomer Sealant Versus Fluoride Varnish Application to Prevent Occlusal Caries Among Preschool Children - a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 3 Years – 5 Years
• Healthy volunteers: Accepted

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.

Detailed description

Topical fluoride varnish (TFV) with 5% sodium fluoride in its content has proven effective in preventing caries among children and adolescents. Its reduction in DMFT is well supported by Cochrane reviews and clinical trials. However, its effect in preventing pit and fissure caries in primary dentition has not been assessed. Pit and fissure sealants have been a recommended procedure in preventing caries development in permanent molars. Multiple systematic reviews and clinical trials have concluded that fissure sealants are significantly more effective than topical fluoride varnishes in preventing occlusal caries in permanent molars. However, a recent Cochrane review suggested that there was still insufficient evidence to determine superiority of resin or glass ionomer fissure sealants over topical fluoride varnishes for occlusal caries prevention, due to the lack of reliable results and low quality of evidence. Also, most studies were conducted on permanent first molars among school children, whom cooperation and moisture control can be easily achieved. However, application of fissure sealants, especially resin-based sealant, in very young children can be a technique-sensitive procedure. Compared with a mean treatment time of less than 3 minutes for varnish application, application of resin-based sealants required over 15 minutes. Moisture control is also of paramount importance for the retention and success of resin-based sealants, which may be difficult among young preschool children. Glass-ionomer sealants can chemically bond to enamel and are more tolerable to inadequate moisture control. As its application requires less clinical steps, glass-ionomer sealant is comparatively more acceptable to younger patients and can be used in outreach settings with a large number of participants. The fluoride releasing ability is also beneficial in preventing caries especially at adjacent tooth surfaces. However, its retention rate is significantly lower than that of resin-based sealants, its success rate in preventing fissure caries in very young patients is still unknown.

Conditions

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

Interventions

Type	Name	Description
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 ®).

Timeline

• Start date: 2018-04-11
• Primary completion: 2021-08-31
• Completion: 2022-12-31
• First posted: 2019-11-14
• Last updated: 2019-11-14

Locations

1 site across 1 country: Hong Kong