Glass-ionomer Cement Containing Chlorhexidine for ART
Primary Purpose
Dental Caries
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ART with GIC containing 1.25% CHX.
ART with GIC.
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, glass ionomer cement, ART
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Teeth with pulpal exposure or the presence of fistula and history of pain were excluded
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ART with GIC containing 1.25% CHX
ART with GIC
Arm Description
The cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).
The cavities were filled with the press finger technique using KetacMolar Easymix® (control group).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Microbiological long-term effect (microbiological assessment of mutans streptococci (MS) counts)
The unstimulated saliva samples were collected for microbiological assessment of mutans streptococci (MS) counts after 7 days, 3 months and 1 year of the dental treatment.
Full Information
NCT ID
NCT02459730
First Posted
May 13, 2015
Last Updated
May 28, 2015
Sponsor
University of Campinas, Brazil
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
1. Study Identification
Unique Protocol Identification Number
NCT02459730
Brief Title
Glass-ionomer Cement Containing Chlorhexidine for ART
Official Title
Glass-ionomer Cement Containing Chlorhexidine for ART
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
ART treatment and follow-up:
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 with one of the randomly selected materials: (1) GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (KM + CHX; n= 41 tooth surfaces) or (2) KetacMolar Easymix® as a control group (KM; n = 66 tooth surfaces). Material excess was removed using carver instrument and the restoration was coated with a layer of petroleum jelly. Multiple-surface cavities were filled after placement of plastic bands and wedges. Both molars (class I and II) and incisors were treated in this study and the same GIC were used for patients who had more than one carious teeth indicated to ART. The children underwent longitudinal clinical follow-up to assess physical condition (partial or complete fractures) of the restoration and the presence of primary or secondary caries at 7 days, 3 months and 1 year, according to ART evaluation criteria by Frencken et al. Children were encouraged and instructed on dental hygiene and received all other necessary oral care.
Microbiological assays:
Unstimulated whole saliva was collected after 7 days, 3 months and 1 year after treatment from each subject by direct expectoration into a 50-ml sterile container for 5-10 min. Pooled supragingival biofilm samples were collected from all buccal and lingual smooth surfaces, except from the interior of the cavities. In order to standardize plaque amount, a sterile plastic disposable inoculating loop with a circular opening of about 1 µL capacity was used for the collection. Collection was stopped when the opening was filled. Biofilm samples were placed immediately into a 1-ml centrifuge microtubes containing Tris-EDTA buffer (10 mM Tris-Hcl, 0.1 mM EDTA, pH 7.5). Collections were performed at least 1 h after feeding. Tubes were transported on ice to laboratory and processed within 2 h.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Dental caries, glass ionomer cement, ART
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ART with GIC containing 1.25% CHX
Arm Type
Experimental
Arm Description
The cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).
Arm Title
ART with GIC
Arm Type
Active Comparator
Arm Description
The cavities were filled with the press finger technique using KetacMolar Easymix® (control group).
Intervention Type
Procedure
Intervention Name(s)
ART with GIC containing 1.25% CHX.
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
ART with GIC.
Intervention Description
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).
Primary Outcome Measure Information:
Title
Clinical long-term effect - Survival Rate
Description
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.
Time Frame
up to 1 year after restorative procedure
Secondary Outcome Measure Information:
Title
Microbiological long-term effect (microbiological assessment of mutans streptococci (MS) counts)
Description
The unstimulated saliva samples were collected for microbiological assessment of mutans streptococci (MS) counts after 7 days, 3 months and 1 year of the dental treatment.
Time Frame
up to 1 year after restorative procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Teeth with pulpal exposure or the presence of fistula and history of pain were excluded
12. IPD Sharing Statement
Learn more about this trial
Glass-ionomer Cement Containing Chlorhexidine for ART
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