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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| ART with Riva Self Cure | Experimental | Occlusal-proximal restoration in primary molars using Riva Self Cure from SDI, encapsulated, pre-dosed and mechanized handling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-efficacy assessment | Treatment costs will be calculated considering professional costs and procedure costs. In order to calculate the professional cost the time spent in each session will be converted in hours and multiplied by the medium income of the dentist per hour as related by the Brazilian Ministry of Labour and Employment ($36,23). On the other hand, to estimate the procedure cost, it will be considered both variable cost, which includes electricity and equipment depreciation, and materials cost. To calculate the equipment depreciation (peripherals, dental chair and instrumental), the investigators will consider their price, the lifespan of five years and a monthly use of 160 hours, using an estimate value per hour of $1,81. All materials used in each procedure will have their specifications and quantity registered. Prices will be inferences from the market value converted in US Dollars and obtained by the medium of the values from different places that commercialized the referred products. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela P Raggio, Professor | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Sao Paulo | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23053709 | Result | 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. | |
| 19709111 | 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. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| 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. |
|
| an average of 24 months |
| 21401749 | 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. |
| 21274581 | 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. |
| 20642467 | 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. |
| 19059689 | 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. |
| 14742648 | 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. |
| 21972457 | 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. |
| 22419315 | 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. |
| 10901411 | 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. |
| 20723019 | 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. |
| 19732191 | 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. |
| 21703078 | 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. |
| 19688227 | 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. |
| 16026667 | 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. |
| 9479925 | 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. |
| 10343087 | 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. |
| 23190278 | 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. |
| 17140533 | 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. |
| 12073723 | 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. |
| 15119869 | 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. |
| 17243467 | 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. |
| 15005472 | 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. |
| 20091655 | 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. |
| 38824540 | Derived | 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. |