Use of Antibacterial Cement in Infected Dentin (AC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jainara Maria Soares Ferreira, University of Pernambuco
ClinicalTrials.gov Identifier:
NCT01449136
First received: August 28, 2011
Last updated: October 5, 2011
Last verified: September 2011
  Purpose

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 Intervention
Dental Caries
Other: Antibacterial cement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by University of Pernambuco:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 45
Study Start Date: January 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01449136

Locations
Brazil
UFPB
João Pessoa, PB, Brazil, 58050000
Sponsors and Collaborators
University of Pernambuco
  More Information

No publications provided by University of Pernambuco

Additional 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
Study First Received: August 28, 2011
Last Updated: October 5, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014