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

NCT ID: NCT02562456

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

428 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-01

Study Completion Date

2019-12-10

Brief Summary

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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.

Detailed Description

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Research setting

The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).

Sample size calculation

For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.

Randomization

The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.

Allocation concealment

To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.

Blinding

Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.

Operators

All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.

Conditions

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Dental Caries

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Conventional Treatment

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

Group Type ACTIVE_COMPARATOR

Conventional Treatment

Intervention Type 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.

ART using Fuji IX

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

Group Type EXPERIMENTAL

ART using Fuji IX

Intervention Type 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.

Interventions

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ART using Fuji IX

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.

Intervention Type PROCEDURE

Conventional Treatment

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Daniela Prócida Raggio

Associate Professor of Pediatric Dentistry Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniela P Raggio, PhD

Role: STUDY_CHAIR

University of Sao Paulo

Locations

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Complexo Educacional Carlos Osmarinho de Lima - Trailer USP

Barueri, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 28698331 (View on PubMed)

Other Identifiers

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RECART

Identifier Type: -

Identifier Source: org_study_id