Use of Antibacterial Cement in Infected Dentin

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: Antibacterial cement

• Registration Number: NCT01449136
• Lead Sponsor: University of Pernambuco

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2011-08-28
• Status Verified: 2011-09
• Study First Submitted QC: 2011-10-05
• Last Update Submitted: 2011-10-05
• Study First Posted: 2011-10-10
• Last Update Posted: 2011-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
antibacterial cement	Antibacterial cement	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UFPB; 🇧🇷 João Pessoa, PB, Brazil