Occlusal ART Restorations in Primary Molars Using 3 Different GIC

Dental Caries Clinical Trial

Official title:

Survival Rate and Cost Effectiveness of Occlusal ART Restorations in Primary Molars Using 3 Different Glass Ionomers Cements - a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377297
• Other study ID #: USPOART2014
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: March 6, 2018

Study information

• Verified date: May 2020
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to evaluate the survival rate and the cost-effectiveness of occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro Molar, DFL) in primary molars.

Description:

Sampling procedure:

This study was approved by the research ethics committee of the School of Dentistry (University of São Paulo, Brazil) and a written informed consent will be obtained from the parents or legal guardians of the participating children. The sample size was calculated based on the minimum difference of 10% in the success rate between the control and treatment groups after 1 year of follow-up, with and α of 5% and power (strength) of 80% using paired test. According to the sample size calculation 150 children aged from 5-8 years old attending public schools from the city of Barueri in the state of São Paulo, Brazil will be selected.

To be included in this study the following criteria must be followed: healthy, cooperative children with at least one occlusal carious lesion in a primary molar extending to the dentin with dimensions not greater than 2 mm occluso-cervical and with an intact edge list. Also, to be included the tooth cannot present ulcer, abscess, fistula, or pathological mobility.

Implementation:

One occlusal restoration per child will be included in this study. If the selected children present more cavities, they will be referred to the health centre of the municipality of Barueri or will be treated by the operators of this research during the training week. All the occlusal and proximal-ART restorations will be performed by two operators on the school premisses. The operators will be final year dental students who will be previously trained to perform ART and to mix the GIC according to the manufacturers' protocol. Additionally, a try-out week will be included to give the operators the opportunity to familiarise themselves with the local conditions prior to the start of the operative phase of the study. The operators will be assisted by a local dentist and a dentist assistant, who will be previously trained to mix the GIC according to the manufacturers' protocol. The children will be randomly assigned into three groups: Fuji IX, Maxxion R, and Vitro Molar and the GIC brand used in each child will be assigned by a random list. The operators are blind for the GIC brand.

Treatment procedure:

The ART technique will be performed according to the ART guidelines proposed by Frencken (2014). No local anaesthesia will be used during treatment. The plaque will be removed and an enamel hatchet will be used to make access to underlying softened dentine. Infected carious dentin will be removed with hand instruments. The use of hand instruments on the dentin surface results in a smear layer and need to be removed by the use of dentine conditioner. The liquid component of the hand-mixed powder-liquid GIC, containing the acid component, will be used and saliva isolation will be done with cotton wool rolls. The cavities will be restored with one of the three GIC brands: Fuji IX (GC Europe, Leuven, BE), Maxxion R (FGM, Rio de Janeiro, BR) and Vitro Molar (DHL, Rio de Janeiro, BR). The GICs will be hand mixed according to the manufacturers´ instructions (powder/liquid ratio 1:1) and will be inserted into the cavity with a conventional application instrument. A thin layer of petroleum jelly will be rubbed over the index finger and the restoration will be pressed for 20 seconds. The material will include sealing pits and the fissure. After preparing for a balanced occlusion, a new layer of petroleum jelly will be applied to the GIC restoration. The amount of GIC used, element number, cavity dimension and dmft will be recorded. The duration of the restorative procedure will be recorded with a stop watch. The participating children will be instructed not to eat for one hour after the restoration is placed.

Estimation of cost-effectiveness:

Effectiveness will be measured in terms of the retention rate. This study will report only the preliminary results after 1 month, but the other follow-ups will be done every 6 months up to 3 years. The average cost per restoration will be estimated. Costs of equipment, autoclave and hand instruments, disposables (hand gloves, face masks, cotton wool rolls), articulating paper and petroleum jelly used for the restorations are equal for all the three GIC groups and will be excluded. There will be no labour costs for the operators. The material cost (powder-liquid GICs) will be estimated per restoration. After this, a analysis for each material will be made to see the cost-effectivess between each material (all the materials used during the restorations) and the retention rate of the restoration.

Evaluation:

The retention rate of the restorations will be evaluated after 1 month according to the modified version of Roeleveld et al. (2006) criteria. A restoration will be considered as 'failure' when there is a defect in the filling, when secondary caries are observed, when the restoration is not present or when the pulp is inflamed. When the restoration is still present or a slight defect is observed, it will be considered as 'success'. When the tooth is unavailable for evaluation, it will be censored. All evaluations will be carried out by one independent evaluator, who did not restore the cavities, trained and calibrated by a benchmark.

The cost effectiveness will be evaluated. The total price of each GIC brand, used to insert into the cavities will be compared to the retention rate of the restorations.

References:

1. 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

2. 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

3. Roshan NM, Sakeenabi B. Survival of occlusal ART restorations in primary molars placed in school environment and hospital dental setup-one year follow-up study. Med Oral Patol Oral Cir Bucal. 2011 Nov 1;16(7):e973-7

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5. 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

6. 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

7. 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

8. Frencken JE. The state-of-the-art of ART restorations. Dent Update. 2014 Apr;41(3):218-20, 222-4

9. Mjör IA, Gordan VV. A review of atraumatic restorative treatment (ART). Int Dent J. 1999 Jun;49(3):127-31

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

11. 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

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16. da Mata C, Allen PF, Cronin M, O'Mahony D, McKenna G, Woods N. Cost-effectiveness of ART restorations in elderly adults: a randomized clinical trial. Community Dent Oral Epidemiol. 2014;42:79-87

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19. Ardenghi TM, Piovesan C, Antunes JL. Inequalities in untreated dental caries prevalence in preschool children in Brazil. Rev Saude Publica. 2013 Dec;47 Suppl 3:129-37

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21. Frencken JE, Leal SC. The correct use of the ART approach. J Appl Oral Sci. 2010;18:1-4

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26. Hickel R, Kaaden C, Paschos E, Buerkle V, García-Godoy F, Manhart J. Longevity of occlusally-stressed restorations in posterior primary teeth. Am J Dent. 2005 Jun;18(3):198-211

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cost analysis of glass ionomer cements - in vitro study. Unpublished data

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 6, 2018
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• healthy

• cooperative

• at least one occlusal carious lesion in a primary molar

• lesion extending to the dentin with dimensions not greater than 2 mm occluso-cervical

• intact edge list

• signed consent form from the responsible part

Exclusion Criteria:

• the tooth cannot present ulcer, abscess, fistula, or pathological mobility

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Restoration with Fuji IX
The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).
• Restoration with Vitro Molar
The cavities will be restored with Vitro Molar (DHL, Rio de Janeiro, BR).
• Restoration with Maxxion R
The cavities will be restored with Maxxion R (FGM, Rio de Janeiro, BR).

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Academic Centre for Dentistry in Amsterdam

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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

Holmgren CJ, Roux D, Doméjean S. Minimal intervention dentistry: part 5. Atraumatic restorative treatment (ART)--a minimum intervention and minimally invasive approach for the management of dental caries. Br Dent J. 2013 Jan;214(1):11-8. doi: 10.1038/sj.bdj.2012.1175. — View Citation

Olegário IC, Pacheco AL, de Araújo MP, Ladewig NM, Bonifácio CC, Imparato JC, Raggio DP. Low-cost GICs reduce survival rate in occlusal ART restorations in primary molars after one year: A RCT. J Dent. 2017 Feb;57:45-50. doi: 10.1016/j.jdent.2016.12.006. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate occlusal restorations between the 3 groups	The evaluation criteria will be that described by Roeleveld et al., 2006, in which scores 00 or 10 will be considered as success. On the other hand, scores 11, 12, 13, 20, 21, 30, 40 or 50 will considered as failure of the restoration. The remaining scores 60, 70 or 90 will not be considered as success or failure (censored data).	Every 6 months up to 2 years
Secondary	Difference differents DMFTs between the patients and the sucess rate of the restoration	Analyse the difference differents DMFTs between the patients and the sucess rate of the restoration. If higher DMFT has some influence in the sucess of the restoration (poor hygiene or big cavities around)	After 2 years
Secondary	Cost analysis between three groups	For cost evaluation, the time of each restorative session will be recorded by an external researcher. All costs, subdivided into materials and professionals costs, measured in Brazilian real and converted to US Dollar (1.0 R$= 0.25U$ dollar) will be considered to analyze baseline cost and an estimation will be done for treatments' cumulative cost.	Every 6 months up to 2 years