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Glass-ionomer Cement Containing Chlorhexidine for ART

NCT02459730 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-06-02

No results posted yet for this study

Summary

This study evaluated the clinical and microbiological long-term effects of 1.25% CHX associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART) technique. Randomized controlled trial was conducted on 40 children with carious lesions that received ART either with GIC containing CHX or GIC only. Survival rate of restorations was checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva samples were collected for microbiological assessment of mutans streptococci (MS) counts. Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p \<0.05).

Conditions

  • Dental Caries

Interventions

PROCEDURE

ART with GIC containing 1.25% CHX.

Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).

PROCEDURE

ART with GIC.

Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using KetacMolar Easymix® (n = 66 tooth surfaces).

Sponsors & Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

    collaborator OTHER_GOV

  • University of Campinas, Brazil

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-02-28
Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02459730 on ClinicalTrials.gov