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Use of Antibacterial Cement in Infected Dentin

NCT ID: NCT01449136

Last Updated: 2011-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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antibacterial cement

Group Type EXPERIMENTAL

Antibacterial cement

Intervention Type OTHER

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

Interventions

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Antibacterial cement

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

Intervention Type OTHER

Other Intervention Names

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Antibacterial cement (Formula & Ação, São Paulo, Brazil)

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pernambuco

OTHER

Sponsor Role lead

Responsible Party

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Jainara Maria Soares Ferreira

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UFPB

João Pessoa, Paraíba, Brazil

Site Status

Countries

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Brazil

References

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Ferreira JM, Pinheiro SL, Sampaio FC, Menezes VA. Use of glass ionomer cement containing antibiotics to seal off infected dentin: a randomized clinical trial. Braz Dent J. 2013;24(1):68-73. doi: 10.1590/0103-6440201301925.

Reference Type DERIVED
PMID: 23657417 (View on PubMed)

Other Identifiers

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1535/07

Identifier Type: -

Identifier Source: org_study_id