Cost-efficacy of Atraumatic Restorations (ART) Using Different Encapsulated Glass Ionomer Cement

NCT02730000 | Completed

• 1 other identifier: RIVAART
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

Brief Summary

Given the clinical damage caused by errors commonly made during the dosage and handling of glass ionomer cement (GIC) of high viscosity powder-liquid type, the use of encapsulated ionomer has been recommended for final restorations. However, the initial cost of the encapsulated MIC is higher when compared to the material handled manually. The objective of this randomized study is to (1) reveal cost-effective in the long run, the encapsulated CIV Riva Self Cure and Equia used as a restorative material in atraumatic restorations (Atraumatic Restorative Treatment), (2) assess whether the type of cavity (occlusal and occlusal-proximal) influences the longevity of atraumatic restorations using encapsulated IC, (3) assess whether the child's caries experience influences the longevity of atraumatic restorations with GIC encapsulated. Children, ages 3 and 7, will be selected in the Tietê-SP municipality. Randomization will be performed in a stratified manner by the conditions: type of cavity and caries experience. 122 ART restorations are performed using encapsulated CIV - Riva Self Cure - SDI and Equia -CG Corp. The restorations will be evaluated after 6, 12 and 18 months by two trained examiners blind to the groups (intra- and inter-rater agreement above 0.7). To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log-rank test. To evaluate the association between longevity and variable Cox regression test will be applied. For the cost analysis will be used analysis of variance.

Conditions

Dental Caries

Keywords

Dental Atraumatic Restorative Treatment; Primary Teeth; Clinical Efficacy; Cost Analysis; Glass Ionomer Cement

Outcome Measures

Primary Outcomes (1)

• Longevity of atraumatic restoration

  The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" 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.

  up to 24 months

Secondary Outcomes (1)

• Cost-efficacy assessment

  an average of 24 months

Study Arms (2)

ART with Equia

ACTIVE COMPARATOR

Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.

Procedure: ART with Equia

ART with Riva Self Cure

EXPERIMENTAL

Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling.

Procedure: ART with Riva Self Cure

Interventions

ART with Equia PROCEDURE

Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.

ART with Equia

ART with Riva Self Cure PROCEDURE

Occlusal-proximal ART restorations in primary molars using Riva Self Cure will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.

ART with Riva Self Cure

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aging between 4 and 8 years
• presenting good health conditions
• whose parents or legal guardians accept and sign the consent form
• with at least one occlusal proximal caries lesion in primary molars
• only 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)

University of Sao Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (25)

• Bonifacio CC, Hesse D, de Oliveira Rocha R, Bonecker M, Raggio DP, van Amerongen WE. Survival rate of approximal-ART restorations using a two-layer technique for glass ionomer insertion. Clin Oral Investig. 2013 Sep;17(7):1745-50. doi: 10.1007/s00784-012-0859-1. Epub 2012 Oct 11.

  PMID: 23053709 RESULT

• Bonifacio CC, Kleverlaan CJ, Raggio DP, Werner A, de Carvalho RC, van Amerongen WE. Physical-mechanical properties of glass ionomer cements indicated for atraumatic restorative treatment. Aust Dent J. 2009 Sep;54(3):233-7. doi: 10.1111/j.1834-7819.2009.01125.x.

  PMID: 19709111 RESULT

• da Franca C, Colares V, Van Amerongen E. Two-year evaluation of the atraumatic restorative treatment approach in primary molars class I and II restorations. Int J Paediatr Dent. 2011 Jul;21(4):249-53. doi: 10.1111/j.1365-263X.2011.01125.x. Epub 2011 Mar 15.

  PMID: 21401749 RESULT

• de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.

  PMID: 21274581 RESULT

• Deepa G, Shobha T. A clinical evaluation of two glass ionomer cements in primary molars using atraumatic restorative treatment technique in India: 1 year follow up. Int J Paediatr Dent. 2010 Nov;20(6):410-8. doi: 10.1111/j.1365-263X.2010.01067.x.

  PMID: 20642467 RESULT

• Dowling AH, Fleming GJ. Are encapsulated anterior glass-ionomer restoratives better than their hand-mixed equivalents? J Dent. 2009 Feb;37(2):133-40. doi: 10.1016/j.jdent.2008.10.006. Epub 2008 Dec 6.

  PMID: 19059689 RESULT

• Frencken JE, Van 't Hof MA, Van Amerongen WE, Holmgren CJ. Effectiveness of single-surface ART restorations in the permanent dentition: a meta-analysis. J Dent Res. 2004 Feb;83(2):120-3. doi: 10.1177/154405910408300207.

  PMID: 14742648 RESULT

• Gibson G, Jurasic MM, Wehler CJ, Jones JA. Supplemental fluoride use for moderate and high caries risk adults: a systematic review. J Public Health Dent. 2011 Summer;71(3):171-84.

  PMID: 21972457 RESULT

• Harris R, Gamboa A, Dailey Y, Ashcroft A. One-to-one dietary interventions undertaken in a dental setting to change dietary behaviour. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD006540. doi: 10.1002/14651858.CD006540.pub2.

  PMID: 22419315 RESULT

• Holmgren CJ, Lo EC, Hu D, Wan H. ART restorations and sealants placed in Chinese school children--results after three years. Community Dent Oral Epidemiol. 2000 Aug;28(4):314-20. doi: 10.1034/j.1600-0528.2000.280410.x.

  PMID: 10901411 RESULT

• Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010 Oct;19(7):512-6. doi: 10.1111/j.1532-849X.2010.00628.x. Epub 2010 Aug 16.

  PMID: 20723019 RESULT

• Kemoli AM, van Amerongen WE. Influence of the cavity-size on the survival rate of proximal ART restorations in primary molars. Int J Paediatr Dent. 2009 Nov;19(6):423-30. doi: 10.1111/j.1365-263X.2009.01013.x. Epub 2009 Sep 1.

  PMID: 19732191 RESULT

• Kemoli AM, Opinya GN, van Amerongen WE, Mwalili SM. Two-year survival rates of proximal atraumatic restorative treatment restorations in relation to glass ionomer cements and Postrestoration meals consumed. Pediatr Dent. 2011 May-Jun;33(3):246-51.

  PMID: 21703078 RESULT

• Mickenautsch S, Yengopal V, Banerjee A. Atraumatic restorative treatment versus amalgam restoration longevity: a systematic review. Clin Oral Investig. 2010 Jun;14(3):233-40. doi: 10.1007/s00784-009-0335-8. Epub 2009 Aug 18.

  PMID: 19688227 RESULT

• van Duinen RN, Kleverlaan CJ, de Gee AJ, Werner A, Feilzer AJ. Early and long-term wear of 'fast-set' conventional glass-ionomer cements. Dent Mater. 2005 Aug;21(8):716-20. doi: 10.1016/j.dental.2004.09.007.

  PMID: 16026667 RESULT

• Mitchell CA, Orr JF, Russell MD. Capsulated versus hand-mixed glass-ionomer luting cements for post retention. J Dent. 1998 Jan;26(1):47-51. doi: 10.1016/s0300-5712(96)00079-6.

  PMID: 9479925 RESULT

• Nyvad B, Machiulskiene V, Baelum V. Reliability of a new caries diagnostic system differentiating between active and inactive caries lesions. Caries Res. 1999 Jul-Aug;33(4):252-60. doi: 10.1159/000016526.

  PMID: 10343087 RESULT

• Raggio DP, Hesse D, Lenzi TL, Guglielmi CA, Braga MM. Is Atraumatic restorative treatment an option for restoring occlusoproximal caries lesions in primary teeth? A systematic review and meta-analysis. Int J Paediatr Dent. 2013 Nov;23(6):435-43. doi: 10.1111/ipd.12013. Epub 2012 Nov 28.

  PMID: 23190278 RESULT

• Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006 Jun;7(2):85-91. doi: 10.1007/BF03320820.

  PMID: 17140533 RESULT

• Smales RJ, Yip HK. The atraumatic restorative treatment (ART) approach for the management of dental caries. Quintessence Int. 2002 Jun;33(6):427-32.

  PMID: 12073723 RESULT

• Takanashi Y, Penrod JR, Lund JP, Feine JS. A cost comparison of mandibular two-implant overdenture and conventional denture treatment. Int J Prosthodont. 2004 Mar-Apr;17(2):181-6.

  PMID: 15119869 RESULT

• van 't Hof MA, Frencken JE, van Palenstein Helderman WH, Holmgren CJ. The atraumatic restorative treatment (ART) approach for managing dental caries: a meta-analysis. Int Dent J. 2006 Dec;56(6):345-51. doi: 10.1111/j.1875-595x.2006.tb00339.x.

  PMID: 17243467 RESULT

• Yu C, Gao XJ, Deng DM, Yip HK, Smales RJ. Survival of glass ionomer restorations placed in primary molars using atraumatic restorative treatment (ART) and conventional cavity preparations: 2-year results. Int Dent J. 2004 Feb;54(1):42-6. doi: 10.1111/j.1875-595x.2004.tb00251.x.

  PMID: 15005472 RESULT

• Walsh T, Worthington HV, Glenny AM, Appelbe P, Marinho VC, Shi X. Fluoride toothpastes of different concentrations for preventing dental caries in children and adolescents. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007868. doi: 10.1002/14651858.CD007868.pub2.

  PMID: 20091655 RESULT

• Garbim JR, Saihara CS, Olegario IC, Hesse D, Araujo MP, Bonifacio CC, Braga MM, Raggio DP. 2-year survival and cost analysis of occlusoproximal ART restorations using encapsulated glass ionomer cement in primary molars: a randomized controlled trial. BMC Oral Health. 2024 Jun 1;24(1):647. doi: 10.1186/s12903-024-04357-9.

  PMID: 38824540 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Daniela P Raggio, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

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: Associated Professor

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: April 6, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)