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| Name | Class |
|---|---|
| Academic Centre for Dentistry in Amsterdam | OTHER |
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The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions.
This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research.The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions.
This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected, 300 patients with one occlusal carie lesion and 300 different patients with occlusal proximal cavities. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research. The remaining carious lesions will be also be treated. The ART treatments will be done by two dental students. The operators will receive the same ART-training.
The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list.
The selected children can have or an occlusal (O) cavity or an occlusalproximal (OP) cavity. So, the stratum of the study is OP and O. So, one randomization list will be performed for occlusal cavities and another randomization list will be used for occlusal proximal cavities.
It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GIC Restorations | Active Comparator | Restorations using Glass Ionomer Cement |
|
| Compomer Restorations | Experimental | Restorations using Compomer |
|
| Carbomer Restorations | Experimental | Restorations using Glass Carbomer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GIC Restorations | Procedure | Restorations using Glass Ionomer Cement |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Survival rate (longevity) of ART restorations using differents materials | The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and occlusoproximal caries in primary molars with ART under field conditions. | 6, 12, 24 and 36 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Association between survival and gender | 6, 12, 24 and 36 months follow-up | |
| Association between survival and DMFT (caries experience) | 6, 12, 24 and 36 months follow-up | |
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Inclusion Criteria:
Inclusion criteria for the patient:
Inclusion criteria for the tooth:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela P Raggio, Professor | Universidade de Sao Paulo - Faculdade de Odontologia | Principal Investigator |
| Isabel O Costa, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry - Sao Paulo University | São Paulo | 05508-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22891625 | Background | Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14. | |
| 21274581 | Background | 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. |
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| Carbomer Restorations |
| Procedure |
Restorations using Glass Carbomer |
|
| Compomer Restorations | Procedure | Restorations using Compomer |
|
| Association between survival and occlusal contact after restoration |
| 6, 12, 24 and 36 months follow-up |
| Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not) | 6, 12, 24 and 36 months follow-up |
| Cost-effectiveness of the 3 materials and their association with survival rate | 6, 12, 24 and 36 months follow-up |
| Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time) | 6, 12, 24 and 36 months follow-up |
| 10773632 | Background | Banerjee A, Kidd EA, Watson TF. In vitro evaluation of five alternative methods of carious dentine excavation. Caries Res. 2000 Mar-Apr;34(2):144-50. doi: 10.1159/000016582. |
| 17140522 | Background | van Bochove JA, van Amerongen WE. The influence of restorative treatment approaches and the use of local analgesia, on the children's discomfort. Eur Arch Paediatr Dent. 2006 Mar;7(1):11-6. doi: 10.1007/BF03320809. |
| 20526266 | Background | Carvalho TS, van Amerongen WE, de Gee A, Bonecker M, Sampaio FC. Shear bond strengths of three glass ionomer cements to enamel and dentine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e406-10. doi: 10.4317/medoral.16.e406. |
| 23408469 | Background | Cehreli SB, Tirali RE, Yalcinkaya Z, Cehreli ZC. Microleakage of newly developed glass carbomer cement in primary teeth. Eur J Dent. 2013 Jan;7(1):15-21. |
| 22124610 | Background | Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29. |
| 16026667 | Background | 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. |
| 17082278 | Background | Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087. |
| 8915958 | Background | Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x. |
| 22137936 | Background | Kuhnisch J, Mansmann U, Heinrich-Weltzien R, Hickel R. Longevity of materials for pit and fissure sealing--results from a meta-analysis. Dent Mater. 2012 Mar;28(3):298-303. doi: 10.1016/j.dental.2011.11.002. Epub 2011 Dec 3. |
| 21332735 | Background | Mickenautsch S, Mount G, Yengopal V. Therapeutic effect of glass-ionomers: an overview of evidence. Aust Dent J. 2011 Mar;56(1):10-5; quiz 103. doi: 10.1111/j.1834-7819.2010.01304.x. |
| 23190278 | Background | 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. |
| 30171345 | Derived | Olegario IC, Hesse D, Mendes FM, Bonifacio CC, Raggio DP. Glass carbomer and compomer for ART restorations: 3-year results of a randomized clinical trial. Clin Oral Investig. 2019 Apr;23(4):1761-1770. doi: 10.1007/s00784-018-2593-9. Epub 2018 Aug 31. |
| ID | Term |
|---|---|
| D001733 | Bites and Stings |
| ID | Term |
|---|---|
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D014947 | Wounds and Injuries |
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