Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars

NCT02562456 | Unknown

• 1 other identifier: RECART
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.

Conditions

Dental Caries

Keywords

Dental Atraumatic Restorative Treatment; Composite Resins; Primary Teeth; Clinical Efficacy; Cost Analysis

Outcome Measures

Primary Outcomes (1)

• The restoration survival

  The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failures" will be analyzed. "Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.

  Every 6 months up to 24 months.

Secondary Outcomes (3)

• Cost-efficacy assessment

  Through study completion, an average of 24 months

• Child self-reported discomfort

  Immediately after treatment

• Cooperation

  Immediately after treatment

Study Arms (2)

Conventional Treatment

ACTIVE COMPARATOR

Occlusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350)

Procedure: Conventional Treatment

ART using Fuji IX

EXPERIMENTAL

Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX

Procedure: ART using Fuji IX

Interventions

ART using Fuji IX PROCEDURE

Occlusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked. For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.

ART using Fuji IX

Conventional Treatment PROCEDURE

Occlusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed. Local anesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Removal of unsupported enamel will be performed using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched using 37% phosphoric acid for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked. an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.

Conventional Treatment

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aging between 3 and 6 years
• presenting good health conditions
• whose parents or legal guardians accept and sign the consent form
• with at least one occlusal or occlusal proximal caries lesion in primary molars
• only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement

You may not qualify if:

• severe behavioral issues
• presence of fistula or abscess near the selected tooth
• presence of pulp exposure in the selected tooth
• presence of mobility in the selected tooth

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Complexo Educacional Carlos Osmarinho de Lima - Trailer USP

Barueri, São Paulo, Brazil

Location

Related Publications (1)

• Ladewig NM, Sahiara CS, Yoshioka L, Olegario IC, Floriano I, Tedesco TK, Mendes FM, Braga MM, Raggio DP. Efficacy of conventional treatment with composite resin and atraumatic restorative treatment in posterior primary teeth: study protocol for a randomised controlled trial. BMJ Open. 2017 Jul 10;7(7):e015542. doi: 10.1136/bmjopen-2016-015542.

  PMID: 28698331 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Daniela P Raggio, PhD

  University of Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatric Dentistry Department

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: September 29, 2015
• Study Start: November 1, 2015
• Primary Completion: June 10, 2018
• Study Completion: December 10, 2019
• Last Updated: December 11, 2018

Record last verified: 2018-12

Locations

BR (1)