Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

Not Applicable

• Conditions: Tooth, Deciduous; Glass Ionomer Cements; Child; Pit and Fissure Caries
• Interventions: Procedure: 5% sodium fluoride varnish (NaF); Procedure: Glass ionomer sealant (GIS)

• Registration Number: NCT04163354
• Lead Sponsor: The University of Hong Kong

Brief 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.

Study Timeline

• Study Start: 2018-04-11
• Status Verified: 2019-11
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-11-12
• Last Update Submitted: 2019-11-12
• Study First Posted: 2019-11-14
• Last Update Posted: 2019-11-14
• Primary Completion: 2021-08-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 348

Inclusion Criteria

Generally healthy children aged between 3-5 years with no remarkable medical history.

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Exclusion Criteria

1. Children with the presence of caries of ICDAS code 3, 4, 5, or 6 on other primary teeth.
2. Children who had received professional fluoride application in the past 6 months.
3. Children with serious systemic disease or taking long term medication.
4. Children who are uncooperative or refuse the treatment.
5. Second primary molars that are (i) with caries in dentin indicated by ICDAS code 4, 5 or 6; (ii) partially erupted; (iii) with fillings and/or sealants; and (iv) hypoplastic or hypomineralized.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaF varnish	5% sodium fluoride varnish (NaF)	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 (GIS)	Glass ionomer sealant (GC Fuji VII® (pink)) on all primary second molars included in the studies, with no further repair/replacement of the sealant

Primary Outcome Measures

Name	Time	Method
Caries increment	24 months	Carious cavity development into dentin (ICDAS code 4, 5 and 6) on the occlusal surfaces of primary second molars over time.

Secondary Outcome Measures

Name	Time	Method
Sealant retention	24 months	Retention of GIS on included primary second molar

Trial Locations

Locations (1)

The University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong