Child Clinical Trial
Official title:
Glass Ionomer Sealant Versus Fluoride Varnish Application to Prevent Occlusal Caries Among Preschool Children - a Randomized Controlled Trial
Verified date | November 2019 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 348 |
Est. completion date | December 31, 2022 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 5 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Department of Health and Human Services |
Hong Kong,
Ahovuo-Saloranta A, Forss H, Hiiri A, Nordblad A, Mäkelä 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;(1):CD003067. doi: 10.1002/14651858.CD003067.pub4. Review. — View Citation
Ahovuo-Saloranta A, Hiiri A, Nordblad A, Worthington H, Mäkelä M. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev. 2004;(3):CD001830. Review. Update in: Cochrane Database Syst Rev. 2008;(4):CD001830. — View 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. — View 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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Sealant retention | Retention of GIS on included primary second molar | 24 months |
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