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

NCT03756025 | Completed

• 1 other identifier: ART-ECC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early Childhood Caries; Atraumatic Restorative Treatment; Glass Ionomer Cement; Deciduous Tooth; Odontopediatrics

Outcome Measures

Primary Outcomes (2)

• Clinical performance scale of restaruations through the ART(Atraumatic Restorative Treatment ) criterion.

  Success: Codes 0(Present, satisfactory), 1(Present, slight deficiency at cavity margin of less than 0.5 mm) and 7(Not present, other restorative treatment performed)

  Through study completion, an average of 1 year

• Clinical performance scale of restaruations through the ART(Atraumatic Restorative Treatment ) criterion.

  Failure: Codes 2(Present, deficiency at cavity margin of 0.5 mm or more), 3(Present, fracture in restoration), 4(Present, fracture in tooth), and 8(Not present, tooth is not present)

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Clinical performance scale of restaruations through the USPHS(United States Public Health Service ) criteria.

  Through study completion, an average of 1 year

• Clinical performance scale of restaruations through the USPHS(United States Public Health Service ) criteria.

  Through study completion, an average of 1 year

Study Arms (2)

Vitro Molar® (DFL, Rio de Janeiro, Brazil)

EXPERIMENTAL

ART restorations of a face with one of the two high-viscosity conventional glass ionomer cements-Vitro Molar® (DFL, Rio de Janeiro, Brazil).

Procedure: Atraumatic Restorative Treatment (ART)

Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).

ACTIVE COMPARATOR

ART restorations of a face with one of the two high-viscosity conventional glass ionomer cements-Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).

Procedure: Atraumatic Restorative Treatment (ART)

Interventions

Atraumatic Restorative Treatment (ART) PROCEDURE

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).

Also known as: ART

Ketac Molar Easy Mix® (3M ESPE, St Paul, MN, USA).; Vitro Molar® (DFL, Rio de Janeiro, Brazil)

Eligibility Criteria

• Age: 18 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• presence of active carious cavitated lesions;
• least one deciduous molar in each of the different dental quadrants;
• caries of shallow or medium depth, involving only the occlusal surface.

You may not qualify if:

• Children who do not allow clinical procedures to be performed.

Sponsors & Collaborators

• Hospital Nossa Senhora da Conceicao: lead

Study Sites (1)

Nossa Senhora da Conceição Hospital

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Related Publications (1)

• Faustino-Silva DD, Figueiredo MC. Atraumatic restorative treatment-ART in early childhood caries in babies: 4 years of randomized clinical trial. Clin Oral Investig. 2019 Oct;23(10):3721-3729. doi: 10.1007/s00784-019-02800-8. Epub 2019 Jan 21.

  PMID: 30666480 DERIVED

MeSH Terms

Interventions

Dental Atraumatic Restorative Treatment

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Each evaluation was performed by a different blind examiner for the type of GIC used in ART Patients did not know what material was being used on their teeth.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: November 28, 2018
• Study Start: June 1, 2008
• Primary Completion: December 31, 2008
• Study Completion: June 1, 2009
• Last Updated: November 28, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)