Use of Antibacterial Cement in Infected Dentin
AC
Phase 1 Study of Clinical and Radiographic Success of Antibacterial Cement in Infected Dentin of Deciduous Teeth
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 28, 2011
CompletedFirst Posted
Study publicly available on registry
October 10, 2011
CompletedOctober 10, 2011
September 1, 2011
2.1 years
August 28, 2011
October 5, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (1)
antibacterial cement
EXPERIMENTALInterventions
Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UFPB
João Pessoa, Paraíba, 58050000, Brazil
Related Publications (1)
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.
PMID: 23657417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 28, 2011
First Posted
October 10, 2011
Study Start
January 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
October 10, 2011
Record last verified: 2011-09