Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: 5% sodium fluoride varnish (NaF)
* Procedure: Glass ionomer sealant (GIS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Generally healthy children aged between 3-5 years with no remarkable medical history. Exclusion Criteria: Children with the presence of caries of ICDAS code 3, 4, 5, or 6 on other primary teeth. Children who had received professional fluoride application in the past 6 months. Children with serious systemic disease or taking long term medication. Children who are uncooperative or refuse the treatment. 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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NaF varnish<br>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; | Procedure: 5% sodium fluoride varnish (NaF)<br>* 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.<br>* Other names: Duraphat, Colgate-Palmolive Ltd, Waltrop, Germany;|
| Experimental: GI sealant<br>Glass ionomer sealant (GC Fuji VII® (pink)) on all primary second molars included in the studies, with no further repair/replacement of the sealant | Procedure: Glass ionomer sealant (GIS)<br>* 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 ®).<br>* Other names: GC Fuji VII® (pink);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries increment | Carious cavity development into dentin (ICDAS code 4, 5 and 6) on the occlusal surfaces of primary second molars over time. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealant retention | Retention of GIS on included primary second molar | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pit and Fissure Sealant, Fluorides, Topical