Impact of Different Restorative Treatments for Deep Caries Lesion in Primary Teeth

Study Overview
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Brief Summary
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In front of a lack of evidence to determine the best treatment for deep cavitated carious lesions, the search for an effective restorative technique, which results in a least possible discomfort to patients, and reduce the time needed for the restorative treatment, if becomes relevant. The objective of this randomized clinical trial to evaluate the efficacy of high viscosity glass ionomer cement restorations (HVGIC) compared to restoration with calcium hydroxide restoration associated with high viscosity glass ionomer cement (HVGIC) for treatment of deep lesions in primary molars, as well as the impact of treatment in the criteria focused on the patient as well as cost-efficacy of the techniques . Children with 4 to 8 years will be selected randomly at the Clinic for Children at the University Ibirapuera of Dentistry. 108 teeth will be randomized into two groups: (1) restoration with calcium hydroxide cement associated with HVGIC and (2) HVGIC restoration. The restorations will be evaluated after 6, 12 and 24 months by two trained examiners blinded to the treatments. The efficacy of each treatment is measured by four main outcomes, which are: (1) criteria related to the effectiveness of the restorative treatment (2) criteria focused on the patient and (3) cost-efficacy. For comparison between the two groups will be used the Kaplan-Meier survival and the long-rank test. Cox regression is performed the assessment of the influence of some other variable results. For all analyzes, the significance level is set at 5%.

Conditions
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Deep Caries Lesion of Primary Teeth

Intervention / Treatment
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* Other: HVGIC
* Other: Indirect pulp capping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children will be included that have at least one primary molar with deep cavitated carious lesions in occlusal surface. Exclusion Criteria: Patients will be excluded with special needs, using orthodontics devices and / or systemic diseases which may affect the oral cavity. Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVGIC<br>Restorations with only HVGIC in deep caries lesion of primary teeth. | Other: HVGIC<br>* In experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion.<br>|
| Active Comparator: Indirect pulp capping<br>Indirect pulp capping with calcium hydroxide cement, restored with HVGIC: | Other: Indirect pulp capping<br>* In control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulp Vitality | To evaluate the survival of different restorative treatments considering the pulp vitality. | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wong-Baker scale to discomfort | To evaluate the discomfort of different restorative treatments by a Wong-Baker scale. | Immediately to restoration procedure. | 
| Cost-efficacy analysis by total value of treatment in relation to efficacy | To evaluate the cost-efficacy of different restorative treatments by total value in dollar of treatment in relation to efficacy. The researchers would like to analyze that a treatment of low cost show the similar efficacy of a high cost treatment. | Up to 24 months | 
| Restoration longevity | To evaluate the restoration longevity by clinical examination. | Up to 24 months. | 
| Caries progression | To evaluate the caries progression by radiography. | Up to 24 months. |