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Atraumatic Restorative Treatment (ART) in Early Childhood Caries (ECC)

NCT03756025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-11-28

No results posted yet for this study

Summary

Considering the severity and high prevalence of ECC, as well as the importance of early intervention and approach, the Atraumatic Restorative Treatment program, because of its advantages, consists of an important treatment alternative. However, only a few studies assess ART in babies affected by ECC. For this practice to be accepted as safe, scientific evidence must be built through longitudinal studies to evaluate ART performance and to this end, the present study is justified. Therefore, the aim of this research was to evaluate the effectiveness of Atraumatic Restorative Treatment performed in babies suffering from ECC after a 4-year period and compare the clinical performance of Atraumatic Restorations performed with two different glass ionomer cements. The investigator's hypothesis is that there is no difference in the clinical performance of ARTs performed with the different GICs.

The study is characterized by longitudinal follow-up of a randomized, double-blind, split-mouth-type clinical trial performed in babies affected by early childhood caries. The subjects were children of both sexes, aged between 18 and 36 months, with at least one deciduous molar in each of the different dental quadrants, presenting active cavitated lesions of shallow or medium depth, involving only the occlusal surface. The initial convenience sample consisted of 100 deciduous molars of 25 children attending Bebê Clínica of the School of Dentistry of the Federal University of Rio Grande do Sul-FO / UFRGS, Porto Alegre-RS, Brazil;

Conditions

  • Early Childhood Caries

Interventions

PROCEDURE

Atraumatic Restorative Treatment (ART)

The atraumatic restorations were performed in the dental office by a single operator trained in the ART Technique \[20\], who received the restorative material already prepared by a trained auxiliary, ensuring blinding of the study. The restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin spoons, with subsequent conditioning of the cavity with a polyacrylic acid solution at 11.5% (DFL) applied with a microbrush for 10 seconds. Immediately after, the cavity was washed and dried with cotton balls. In this step, according to the randomization, the respective GIC was inserted and subsequent digital compression was performed for 30 seconds. After occlusal adjustment, the ARTs were protected with finish gloss Alfa Bond® (DFL).

Sponsors & Collaborators

  • Hospital Nossa Senhora da Conceicao

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
36 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-01
Primary Completion
2008-12-31
Completion
2009-06-01

Countries

  • Brazil

Study Locations

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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 NCT03756025 on ClinicalTrials.gov