Viewing Study NCT01449136



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Study NCT ID: NCT01449136
Status: COMPLETED
Last Update Posted: 2011-10-10
First Post: 2011-08-28

Brief Title: Use of Antibacterial Cement in Infected Dentin
Sponsor: University of Pernambuco
Organization: University of Pernambuco

Study Overview

Official Title: Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
Status: COMPLETED
Status Verified Date: 2011-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: AC
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 n22 the cavities were lined with conventional glass ionomer cement Vidrion F and in group B GB n23 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None