NCT01881100

Brief Summary

It was hypothesized that resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth reduce considerably the progression of treated caries lesions, compared to fluoride varnish therapy only.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2013

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

1.3 years

First QC Date

June 16, 2013

Last Update Submit

June 16, 2013

Conditions

White Spot LesionsCaries

Keywords

resin infiltrationrandomized clinical trialfluoride varnishcaries lesiondeciduous teeth

Outcome Measures

Primary Outcomes (1)

  • Resin infiltration in conjunction with fluoride varnish treatment of smooth-surface caries lesions in deciduous teeth versus fluoride varnish therapy only.

    The condition of treated white spot lesions (WSL) were scored using the Nyvad et al. system (17): I-WSL (Inactive WSL) - inactive spot lesion, when surface was becoming smooth, hard and glossy; S -WSL (Sound WSL) - invisible spot lesion taking the appearance of healthy enamel with proper translucency level and surface texture. Active enamel lesions and assessment scores 3-6 according to ICDAS II within a year were considered as decayed (D-Enamel/Dental cavity). Treatment was considered successful when lesions did not progress (I-WSL or S-WSL); unsuccessful when lesions remained active and enamel underwent erosion - i.e. caries occurred (D).

    one year

Study Arms (2)

resin infiltration

EXPERIMENTAL

The test group (41 children) had caries lesions treated with the infiltration technique using Icon (DMG, Hamburg, Germany) and fluoride varnish (Duraphat, Colgate Palmolive, Hamburg, Germany)at baseline evaluation. Fluoride varnish was applied every control visit every three months during 1 year.

Other: resin infiltrationOther: fluoride varnish

fluoride varnish

ACTIVE COMPARATOR

The control group (40 children) had all tooth surfaces including WSL treated with fluoride varnish (Duraphat Colgate Palmolive, Hamburg, Germany)only at baseline evaluation and every control visit every three months during 1 year.

Other: fluoride varnish

Interventions

resin infiltrationOTHER

The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.

Also known as: Icon DMG Germany, Duraphat Colgate Palmolive Germany
resin infiltration
fluoride varnishOTHER

All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).

Also known as: Duraphat Colgate Palmolive, Hamburg, Germany
fluoride varnishresin infiltration

Eligibility Criteria

Age18 Months - 71 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • at least two active smooth-surface caries lesions in deciduous teeth (ICDAS II code 2)
  • a written consent of parents/ guardians for participation in the research study

You may not qualify if:

  • age above 5.9 years
  • systematic disease
  • cavitated lesions
  • enamel defects
  • current participation in another study
  • a planned change of residence within one year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dorota Olczak-Kowalczyk

Warsaw, Warsaw, 18 Miodowa Saint, 00-246, Poland

Location

Study Officials

  • Dorota Olczak-Kowalczyk, Ass. Prof.

    Warsaw Medical University, 61 Żwirki i Wigury St.,02-091Warsaw

    STUDY DIRECTOR

  • Dorota Olczak-Kowalczyk, Ass.Prof.

    Warsaw Medical University, Poland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd,MD

Study Record Dates

First Submitted

June 16, 2013

First Posted

June 19, 2013

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

August 1, 2012

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

PL(1)