Use of Antibacterial Cement in Infected Dentin (AC)
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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 |
- 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 |
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 More Information
No publications provided
| 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 May 19, 2013