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AC: Use of Antibacterial Cement in Infected Dentin

Sponsor
University of Pernambuco (Other)
Overall Status
Completed
CT.gov ID
NCT01449136
Collaborator
(none)
45
Enrollment
1
Location
1
Arm
25
Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Antibacterial cement
 N/A

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 Design

Study Type:
Interventional
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 :
Jan 1, 2008
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: antibacterial cement

Other: Antibacterial cement
Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
Other Names:
  • Antibacterial cement (Formula & Ação, São Paulo, Brazil)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. number of successful restorations with a dental liner with antibiotics [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 8 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UFPB João Pessoa PB Brazil 58050000

    Sponsors and Collaborators

    • University of Pernambuco

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jainara Maria Soares Ferreira, Principal investigator, University of Pernambuco
    ClinicalTrials.gov Identifier:
    NCT01449136
    Other Study ID Numbers:
    • 1535/07
    First Posted:
    Oct 10, 2011
    Last Update Posted:
    Oct 10, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Jainara Maria Soares Ferreira, Principal investigator, University of Pernambuco
    Antibacterial agents
    Deciduous Teeth
    Clinical Trial
    Additional relevant MeSH terms:
    Dental Caries
    Anti-Bacterial Agents

    Study Results

    No Results Posted as of Oct 10, 2011