Glass-ionomer Cement Containing Chlorhexidine for ART
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
This study evaluated the clinical and microbiological long-term effects of 1.25% CHX associated with GIC applied in primary molars using Atraumatic Restorative Treatment (ART) technique. Randomized controlled trial was conducted on 40 children with carious lesions that received ART either with GIC containing CHX or GIC only. Survival rate of restorations was checked at 3 days, 3 months and 1 year after their placement when the unstimulated saliva samples were collected for microbiological assessment of mutans streptococci (MS) counts. Data were analyzed using ANOVA/Tukey or Kruskal-Wallis/Mann-Whitney tests (p \<0.05).
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 Feb 2013
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
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
June 2, 2015
CompletedJune 2, 2015
May 1, 2015
Same day
May 13, 2015
May 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical long-term effect - Survival Rate
Randomized controlled trial was conducted on 40 children with carious lesions that received ART either with GIC containing CHX or GIC only. Survival rate of restorations was checked after 7 days, 3 months and 1 year of their placement.
up to 1 year after restorative procedure
Secondary Outcomes (1)
Microbiological long-term effect (microbiological assessment of mutans streptococci (MS) counts)
up to 1 year after restorative procedure
Study Arms (2)
ART with GIC containing 1.25% CHX
EXPERIMENTALThe cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).
ART with GIC
ACTIVE COMPARATORThe cavities were filled with the press finger technique using KetacMolar Easymix® (control group).
Interventions
Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).
Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using KetacMolar Easymix® (n = 66 tooth surfaces).
Eligibility Criteria
You may qualify if:
- Good general health
- At least one cavitated dentin carious lesion in primary molars or incisors that had an opening wide enough for the smallest ART excavator access
You may not qualify if:
- Teeth with pulpal exposure or the presence of fistula and history of pain were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postdoctoral scholar
Study Record Dates
First Submitted
May 13, 2015
First Posted
June 2, 2015
Study Start
February 1, 2013
Primary Completion
February 1, 2013
Study Completion
February 1, 2014
Last Updated
June 2, 2015
Record last verified: 2015-05