Back to resultsUse of Antibacterial Cement in Infected Dentin (AC)
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Antibacterial cement
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Antibacterial agents, Deciduous Teeth, Clinical Trial
Eligibility 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.
Sites / Locations
- UFPB
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
antibacterial cement
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01449136
First Posted
August 28, 2011
Last Updated
October 5, 2011
Sponsor
University of Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT01449136
Brief Title
Use of Antibacterial Cement in Infected Dentin
Acronym
AC
Official Title
Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Antibacterial agents, Deciduous Teeth, Clinical Trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
antibacterial cement
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Antibacterial cement
Other Intervention Name(s)
Antibacterial cement (Formula & Ação, São Paulo, Brazil)
Intervention Description
Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
Primary Outcome Measure Information:
Title
number of successful restorations with a dental liner with antibiotics
Description
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.
Time Frame
differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
UFPB
City
João Pessoa
State/Province
PB
ZIP/Postal Code
58050000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
23657417
Citation
Ferreira JM, Pinheiro SL, Sampaio FC, Menezes VA. Use of glass ionomer cement containing antibiotics to seal off infected dentin: a randomized clinical trial. Braz Dent J. 2013;24(1):68-73. doi: 10.1590/0103-6440201301925.
Results Reference
derived
Learn more about this trial
Use of Antibacterial Cement in Infected Dentin
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