Cost-effectiveness of ART Using Encapsulated or Powder-liquid Glass Ionomer Cement: Clinical Trial
This trial is active, not recruiting.
|Treatments||art with powder-liquid material, art with encapsulated material, encapsulated glass ionomer cement (equia - gc corp)., powder-liquid glass ionomer cement (fuji ix - gc corp)|
|Sponsor||University of Sao Paulo|
|Collaborator||Academic Centre for Dentistry in Amsterdam|
|Start date||October 2014|
|End date||October 2016|
|Trial size||122 participants|
|Trial identifier||NCT02274142, ARTCARDEC|
The aim of this protocol is to evaluate the cost-efficacy of different glass ionomer cements in Atraumatic Restorative Treatment restorations, with different handling characteristics: powder-liquid versus encapsulated.
|Endpoint classification||efficacy study|
|Intervention model||factorial assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
time frame: 24 months
time frame: 24 months
time frame: 6 months
time frame: 12 months
Male or female participants from 4 years up to 8 years old.
Inclusion Criteria: - Children with dentinal caries Exclusion Criteria: - systemic problems - refusal of treatment
|Official title||Randomized Clinical Trial, Double-blinded on ART Restorations|
|Principal investigator||Daniela Raggio, Professor|
|Description||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. As more then one tooth might be enrolled in treatment, we must add a 20% for clustering, and also 20% for possible losses. 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 occlusal-cervical and with an intact edge list. Also, to be included the tooth cannot present ulcer, abscess, fistula, or pathological mobility. Implementation: All the occlusal and proximal-ART restorations will be performed by two operators on dental chair. 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 two groups: Hand mixed and encapsulated materials. 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. 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 two GIC brands: Fuji IX (GC Europe, Leuven, BE) and EQUIA (GC Europe, Leuven, BE). 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 6 months, but the other follow-ups will be done every 6 months up to 2 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. Evaluation: The retention rate of the restorations will be evaluated after 6 months according to the Frencken and Holmgren criteria for occlusal surfaces, and modified version of Roeleveld et al. (2006) criteria for occlusal-proximal surfaces; 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.|
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