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Use of Antibacterial Cement in Infected Dentin (AC)

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ClinicalTrials.gov Identifier: NCT01449136
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : October 10, 2011
Information provided by (Responsible Party):
Jainara Maria Soares Ferreira, University of Pernambuco

Brief Summary:
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.

Condition or disease Intervention/treatment
Dental Caries Other: Antibacterial cement

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
Study Start Date : January 2008
Primary Completion Date : February 2010
Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: antibacterial cement Other: Antibacterial cement
Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
Other Name: Antibacterial cement (Formula & Ação, São Paulo, Brazil)

Primary Outcome Measures :
  1. number of successful restorations with a dental liner with antibiotics [ Time Frame: differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months. ]

    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.

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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449136

João Pessoa, PB, Brazil, 58050000
Sponsors and Collaborators
University of Pernambuco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jainara Maria Soares Ferreira, Principal investigator, University of Pernambuco
ClinicalTrials.gov Identifier: NCT01449136     History of Changes
Other Study ID Numbers: 1535/07
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: September 2011

Keywords provided by Jainara Maria Soares Ferreira, University of Pernambuco:
Antibacterial agents
Deciduous Teeth
Clinical Trial

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Anti-Infective Agents