Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Child
- Glass Ionomer Cements
- Pit and Fissure Caries
- Tooth, Deciduous
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: A parallel design model with 2 treatment arms: NaF varnish: Application of a 5% NaF varnish (Duraphat, Colgate-Palmolive Ltd, Waltrop, Germany) on the occlusal surfaces of primary second molars and all other teeth, every 3 months during the study period; GI sealant: Glass ionomer sealant (GC Fuji VII® (pink)) on all primary second molars included in the studies, with no further repair/replacement of the sealant Masking: None (Open Label)Masking Description: Blinding is not possible as pink glass ionomer sealants will be placed on the primary molars of one of the groups.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 3 years and 5 years
- Gender
- Both males and females
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 dentiti...
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.
Tracking Information
- NCT #
- NCT04163354
- Collaborators
- Department of Health and Human Services
- Investigators
- Principal Investigator: Cynthia Kar Yung Yiu, FHKAM,FCDSHK The University of Hong Kong
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