Use of Antibacterial Cement in Infected Dentin

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UFPB

João Pessoa, Paraíba, 58050000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antibacterial cement

Other

Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor

Other names: Antibacterial cement (Formula & Ação, São Paulo, Brazil)

Primary outcomes

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.

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.

Sponsors and collaborators

Lead sponsor

University of Pernambuco

Other

Registry information

Official study title

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

Acronym: AC

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Oct 10, 2011
Registry last updated: Oct 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed