The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations

Dental Caries Extending Into Dentine Clinical Trial

— ARTUSP  

Official title:

The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02217098
• Other study ID #: FOUSP6808912
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: September 10, 2018

Study information

• Verified date: November 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: September 10, 2018
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for the patient:

• Healthy children, age: 4-8 years

• At least one occlusal or proximal carious lesion in primary molar involving dentin

• Cooperative behavior

• Presence of antagonist of the tooth

Inclusion criteria for the tooth:

• Carious lesion involving dentin with dimensions bucco-lingual and mesio-distal not greater than 2.5mm, occluso-cervical not greater than 2.0mm

• Absence of tooth mobility and abscess or fistula near to the selected tooth

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Caries Involving Multiple Surfaces of Tooth
• Dental Caries
• Dental Caries Extending Into Dentine
• Dental Caries on Chewing Surface of Tooth

Intervention

Procedure:
• GIC Restorations
Restorations using Glass Ionomer Cement
• Carbomer Restorations
Restorations using Glass Carbomer
• Compomer Restorations
Restorations using Compomer

Locations

Country	Name	City	State
Brazil	School of Dentistry - Sao Paulo University	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Daniela Prócida Raggio	Academic Centre for Dentistry in Amsterdam

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

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. — View Citation

Bonifácio CC, Hesse D, Raggio DP, Bönecker 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. — View Citation

Carvalho TS, van Amerongen WE, de Gee A, Bönecker 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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Ersin NK, Candan U, Aykut A, Onçag 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. — View Citation

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. — View Citation

Kühnisch 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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Association between survival and gender		6, 12, 24 and 36 months follow-up
Secondary	Association between survival and DMFT (caries experience)		6, 12, 24 and 36 months follow-up
Secondary	Association between survival and occlusal contact after restoration		6, 12, 24 and 36 months follow-up
Secondary	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
Secondary	Cost-effectiveness of the 3 materials and their association with survival rate		6, 12, 24 and 36 months follow-up
Secondary	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