Glass Ionomer Sealant Versus Fluoride Varnish on Occlusal Caries Prevention

NCT04163354 | Unknown

• 1 other identifier: HMRF project 16172221
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Pit and Fissure Sealant; Fluorides, Topical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sealant retention

  24 months

Study Arms (2)

NaF varnish

ACTIVE COMPARATOR

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)

GI sealant

EXPERIMENTAL

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)

Interventions

5% sodium fluoride varnish (NaF) PROCEDURE

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.

Also known as: Topical fluoride varnish, Duraphat, Colgate-Palmolive Ltd, Waltrop, Germany

NaF varnish

Glass ionomer sealant (GIS) PROCEDURE

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 ®).

Also known as: GC Fuji VII® (pink)

GI sealant

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, 999077, Hong Kong

Location

Related Publications (5)

• 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.

  PMID: 15266455 BACKGROUND

• 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.

  PMID: 24290544 BACKGROUND

• 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.

  PMID: 19772849 BACKGROUND

• 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.

  PMID: 26780162 BACKGROUND

• 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.

  PMID: 34284374 DERIVED

MeSH Terms

Conditions

Van der Woude syndrome

Interventions

sodium fluoride topical preparation; Fuji VII

Study Officials

• Cynthia Kar Yung Yiu, FHKAM,FCDSHK

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding is not possible as pink glass ionomer sealants will be placed on the primary molars of one of the groups.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Paediatric Dentistry

Model Details: 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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 14, 2019
• Study Start: April 11, 2018
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2022
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)