Use of Antibacterial Cement in Infected Dentin

Study Overview
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Brief Summary
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Dental materials with antibacterial properties can prevent the harmful effects caused by oral cariogenic bacteria. This double-blind controlled clinical trial evaluated the performance of antibacterial cement for sealing infected dentin in atraumatic restorations of primary molars.

Detailed Description
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The study enrolled 45 children (45 teeth) between 5 and 8 years of age, of both genders, divided into two groups. In group A (GA; n=22), the cavities were lined with conventional glass ionomer cement (Vidrion F®) and in group B (GB; n=23), with antibacterial cement (Vidrion F® containing 1% each of metronidazole, ciprofloxacin, and cefaclor). Both groups were restored with Ketac Molar Easymix®. Molars with carious lesions on the inner half of dentin without clinical or radiographic pulp damage were selected. Patients were evaluated clinically (for pain, fistulas, or mobility) and radiographically (area of caries, periapical region, and furcation of teeth) after 1, 3, 6, and 12 months.

Official Title
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Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Antibacterial cement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed consent from a parent or guardian; primary molars with carious lesions on the inner half of dentin; access of caries lesions to dentin spoons. Exclusion Criteria: damaged pulp determined clinically (for pain, fistulas, tooth mobility); damaged pulp determined radiography (bone or dental pathology); children taking antibiotics; children who refused the treatment; children had systemic disease.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: antibacterial cement<br> | Other: Antibacterial cement<br>* Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor<br>* Other names: Antibacterial cement (Formula & Ação, São Paulo, Brazil);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of successful restorations with a dental liner with antibiotics | The absence of pain, fistulas, and mobility throughout the study was considered clinical success and the decreased or unchanged area of caries (obtained by a software to accurately measure distances between anatomical points selected by the operator of radiolucent zone beneath the restoration) and no bone or dental disorder was detected was considered radiographic success. Overall success was defined as clinical and radiographic success being achieved simultaneously. | differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibacterial agents, Deciduous Teeth, Clinical Trial