Clinical trial NCT04163354: Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention
Official title: Glass Ionomer Sealant Versus Fluoride Varnish Application to Prevent Occlusal Caries Among Preschool Children - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pit and Fissure Caries
Glass Ionomer Cements
Tooth, Deciduous
Child
Keywords: Pit and Fissure Sealant
Fluorides, Topical
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2019-11-14
Enrollment: 348
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel design model with 2 treatment arms:

1. 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;
2. 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
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

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.

Primary outcomes:
measure: Caries increment
timeFrame: 24 months
Secondary outcomes:
measure: Sealant retention
timeFrame: 24 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Cynthia Kar Yung Yiu, FHKAM,FCDSHK
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ahovuo-Saloranta A, Hiiri A, Nordblad A, Worthington H, Makela M. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2004;(3):CD001830. doi: 10.1002/14651858.CD001830.pub2.
citation: American Academy of Pediatric Dentistry. Guideline on caries-risk assessment and management for infants, children, and adolescents. Pediatr Dent. 2013 Sep-Oct;35(5):E157-64. No abstract available.
citation: Marinho VC. Cochrane reviews of randomized trials of fluoride therapies for preventing dental caries. Eur Arch Paediatr Dent. 2009 Sep;10(3):183-91. doi: 10.1007/BF03262681.
citation: Ahovuo-Saloranta A, Forss H, Hiiri A, Nordblad A, Makela M. Pit and fissure sealants versus fluoride varnishes for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2016 Jan 18;2016(1):CD003067. doi: 10.1002/14651858.CD003067.pub4.
citation: Ying Lam PP, Sardana D, Luo W, Ekambaram M, Man Lee GH, Man Lo EC, Yung Yiu CK. Glass Ionomer Sealant versus Fluoride Varnish Application to Prevent Occlusal Caries in Primary Second Molars among Preschool Children: A Randomized Controlled Trial. Caries Res. 2021;55(4):322-332. doi: 10.1159/000517390. Epub 2021 Jul 20.