EFFECTIVENESS OF FLUORIDE RELEASING SEALANT AND FLUORIDE VARNISH ON MANAGEMENT OF INITIAL PROXIMAL CARIES IN PERMANENT TEETH

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20191027003

Enrollment

Registered

2019-10-27

Start date

2019-06-25

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proximal surface of permanent teeth with carious lesion from radiographic examination limited from outer1/2 enamel to outer1/3 dentine without cavity of dentine lesion after separate by orthodontic el

Interventions

Proximal surfaces are etched with 37%phosphoric acid(3M ESPE Scotchbond Universal Etchant) for 20 seconds&#44

then thoroughly rinse with air/water spray to remove etchant&#44

air&#45

drying until the etched surface appear frosty white&#44

apply sealant(Helioseal F) with tip cover the carious lesions&#44

and light&#45

cured for 20 seconds. After that the sealants are checked by explorer for retention.,Proximal surfaces apply fluoride varnish(5% Sodium fluoride) with microbrush&#44

and post op instruction

Experimental Other,Experimental Other

Fluoride releasing sealant,Fluoride varnish

Eligibility

Sex/Gender

All

Age

7 Years to 15 Years

Inclusion criteria

Inclusion criteria: Healthy children age 7 to 15 years old that cooperative behaviour during dental procedure Volunteer under consent form from their parents or caregivers Previously untreated of two permanent posterior teeth in contralateral side with proximal caries lesions having depth of 1-3 of ICCMS radiographic score (radiolucency in outer half of enamel to outer third of dentin) which have tooth contact, without frank cavity of dentine lesion after separate with orthodontic elastic band

Exclusion criteria

Exclusion criteria: Children with asthma or history allergy of constituents of the fluoride varnish e.g. colophony Detection by visual and tactile examination have cavitated lesions at proximal area or presence of advanced dentine caries lesions detected by bitewing radiographic examinations (radiographic score 4-6) Teeth with enamel defect such as enamel hypoplasia,amelogenesis imperfecta Adjacent surface of treatment had restoration with glass ionomer Children received professional fluoride when 3 three months ago

Design outcomes

Primary

Measure	Time frame
Progression 3,6,9,12 months Clinical and Radiographic examination	—

Secondary

Measure	Time frame
N/A N/A N/A	—

Countries

Thailand

Contacts

Public ContactYodkwan Treeratweerapong

Faculty of Dentistry, Mahidol University

chinamon_kwanzez@hotmail.com0895981585

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026