Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial
NCT ID: NCT02962713
Last Updated: 2021-03-03
Study Results
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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COMPLETED
NA
182 participants
INTERVENTIONAL
2017-11-06
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ART with Equia
Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.
ART with Equia
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 Giomer Beautifil-Bulk Restorative
Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc)
ART with Giomer Beautifil-Bulk Restorative
Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.
Interventions
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ART with Equia
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 Giomer Beautifil-Bulk Restorative
Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.
Eligibility Criteria
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Inclusion Criteria
* Children presenting good health conditions
* Children whose parents or legal guardians accept and sign the consent form
* Children with at least one occlusal proximal caries lesion in primary molars
* only occlusal-proximal surfaces with caries lesions with dentin involvement
Exclusion Criteria
* presence of fistula or abscess near the selected tooth
* presence of pulp exposure in the selected tooth
* presence of mobility in the selected tooth
4 Years
8 Years
ALL
No
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Daniela Prócida Raggio
Professor
Principal Investigators
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Daniela P Raggio, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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University of Sao Paulo
São Paulo, , Brazil
Countries
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References
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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.
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.
ten Berge M, Hoogstraten J, Veerkamp JS, Prins PJ. The Dental Subscale of the Children's Fear Survey Schedule: a factor analytic study in The Netherlands. Community Dent Oral Epidemiol. 1998 Oct;26(5):340-3. doi: 10.1111/j.1600-0528.1998.tb01970.x.
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.
Sunico MC, Shinkai K, Katoh Y. Two-year clinical performance of occlusal and cervical giomer restorations. Oper Dent. 2005 May-Jun;30(3):282-9.
Shimazu K, Oguchi R, Takahashi Y, Konishi K, Karibe H. Effects of surface reaction-type pre-reacted glass ionomer on oral biofilm formation of Streptococcus gordonii. Odontology. 2016 Sep;104(3):310-7. doi: 10.1007/s10266-015-0217-2. Epub 2015 Aug 30.
Sheiham A. Dental caries affects body weight, growth and quality of life in pre-school children. Br Dent J. 2006 Nov 25;201(10):625-6. doi: 10.1038/sj.bdj.4814259.
Sengul F, Gurbuz T. Clinical Evaluation of Restorative Materials in Primary Teeth Class II Lesions. J Clin Pediatr Dent. 2015 Summer;39(4):315-21. doi: 10.17796/1053-4628-39.4.315.
Schriks MC, van Amerongen WE. Atraumatic perspectives of ART: psychological and physiological aspects of treatment with and without rotary instruments. Community Dent Oral Epidemiol. 2003 Feb;31(1):15-20. doi: 10.1034/j.1600-0528.2003.00021.x.
Santamaria R, Innes N. Trial shows partial caries removal is an effective technique in primary molars. Evid Based Dent. 2014 Sep;15(3):81-2. doi: 10.1038/sj.ebd.6401044.
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.
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.
Phantumvanit P, Songpaisan Y, Pilot T, Frencken JE. Atraumatic restorative treatment (ART): a three-year community field trial in Thailand--survival of one-surface restorations in the permanent dentition. J Public Health Dent. 1996;56(3 Spec No):141-5; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02424.x.
Oscarson N, Kallestal C, Fjelddahl A, Lindholm L. Cost-effectiveness of different caries preventive measures in a high-risk population of Swedish adolescents. Community Dent Oral Epidemiol. 2003 Jun;31(3):169-78. doi: 10.1034/j.1600-0528.2003.00033.x.
Ngo HC, Mount G, Mc Intyre J, Tuisuva J, Von Doussa RJ. Chemical exchange between glass-ionomer restorations and residual carious dentine in permanent molars: an in vivo study. J Dent. 2006 Sep;34(8):608-13. doi: 10.1016/j.jdent.2005.12.012. Epub 2006 Mar 15.
Miki S, Kitagawa H, Kitagawa R, Kiba W, Hayashi M, Imazato S. Antibacterial activity of resin composites containing surface pre-reacted glass-ionomer (S-PRG) filler. Dent Mater. 2016 Sep;32(9):1095-102. doi: 10.1016/j.dental.2016.06.018. Epub 2016 Jul 12.
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.
Abanto J, Paiva SM, Sheiham A, Tsakos G, Mendes FM, Cordeschi T, Vidigal EA, Bonecker M. Changes in preschool children's OHRQoL after treatment of dental caries: responsiveness of the B-ECOHIS. Int J Paediatr Dent. 2016 Jul;26(4):259-65. doi: 10.1111/ipd.12192. Epub 2015 Sep 15.
Amaral MT, Guedes-Pinto AC, Chevitarese O. Effects of a glass-ionomer cement on the remineralization of occlusal caries--an in situ study. Braz Oral Res. 2006 Apr-Jun;20(2):91-6. doi: 10.1590/s1806-83242006000200001.
Anusavice KJ. Preservative dentistry: the standard of care for the 21st century. J Public Health Dent. 1995 Spring;55(2):67-8. doi: 10.1111/j.1752-7325.1995.tb02334.x. No abstract available.
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.
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.
Other Identifiers
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GIOMERART
Identifier Type: -
Identifier Source: org_study_id
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