Use of Antibacterial Cement in Infected Dentin

Dental Caries Clinical Trial

— AC  

Official title:

Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449136
• Other study ID #: 1535/07
• Status: Completed
• Phase: N/A
• First received: August 28, 2011
• Last updated: October 5, 2011
• Start date: January 2008
• Est. completion date: February 2010

Study information

• Verified date: September 2011
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• Antibacterial cement
Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor

Locations

Country	Name	City	State
Brazil	UFPB	João Pessoa	PB

Sponsors (1)

Lead Sponsor	Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	differences of overall success between baseline and the evaluations performed at 1, 3, 6, and 12 months.	Yes