Clinical Evaluation of Posterior Direct Restoration in Adolescents

Study Overview
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Brief Summary
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The present study aims to evaluate the performance of direct restorations with bulk fill resins in molars with great structural loss, with endodontic treatment. The behavior of class II restorations in 68 molars endodontically treated with bulk fill resin and incremental technique will be evaluated by means of a randomized clinical trial with a two-year follow-up. This project aims to evaluate the performance of this new restorative strategy that can greatly contribute to restorations of posterior teeth.

Detailed Description
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Sixty-eight endodontically treated molars were restored in 54 adolescents (10-18 years old, mean= 14.0 +- 2.4). Teeth were randomly assigned to the incremental filling technique (Filtek Z230/Vitremer, 3M-ESPE, n = 31) or high viscosity bulk fill technique (Filtek Bulk Fill Posterior, 3M-ESPE, n = 37). The restorations were clinically evaluated at baseline, 12 and 24 months by two independent raters using modified United States Public Health Service criteria. Data analysis included descriptive statistics, Mann-Whitney and Friedman non-parametric tests, and Generalized Estimating Equation (GEE) analysis.

Official Title
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Clinical Evaluation of Posterior Direct Restoration in Adolescents

Conditions
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Composite Resins

Intervention / Treatment
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* Procedure: Direct composite resin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents with necessity of endodontic treatment in molar teeth, to be aged between 10 and 18 years; Patients that require direct restorations in Class II MOD cavities in molar teeth; Patients with medical history that does not compromise the evolution of the results; Patients that have a habit of oral hygiene involving brushing teeth at least once a day; Patients that have normal periodontal condition against the probing parameters. Exclusion Criteria: Patients with some chronic disease with oral manifestations; Patients who present some serious oral pathology; Patients with no oral hygiene; Patients with allergies to any material that will be used on this study; Patients presenting with signs or symptoms of bruxism and dental tightening; Patients with teeth that will be used as a pillar for removable prosthesis or fixed partial dentures; Patients with teeth with porcelain restorations directly opposite the tooth that will receive the restoration.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 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 |
| --- | --- |
| Active Comparator: Incremental filling technique<br>Glass ionomer in the pulp chamber and incremental filling technique using composite resin | Procedure: Direct composite resin<br>* For both groups: The teeth will have the enamel surface conditioned with 37% phosphoric acid. For the restorative procedure, the same adhesive system will be used GROUP ACTIVE COMPARATOR Insert resin-modified glass ionomer cement into the pulp chamber; Complete the restoration by incremental technique using conventional composite resin in increments of 2mm; EXPERIMENTAL GROUP Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm; Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal<br>|
| Experimental: Bulk Fill<br>Bulk fill composite resin filling all the cavity | Procedure: Direct composite resin<br>* For both groups: The teeth will have the enamel surface conditioned with 37% phosphoric acid. For the restorative procedure, the same adhesive system will be used GROUP ACTIVE COMPARATOR Insert resin-modified glass ionomer cement into the pulp chamber; Complete the restoration by incremental technique using conventional composite resin in increments of 2mm; EXPERIMENTAL GROUP Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm; Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| restoration failure | material fraction | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| marginal staining | color alteration in the adhesive interface | 2 years |