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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
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring Dental caries, glass ionomer cement, ART

Eligibility Criteria

3 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    May 13, 2015
    Last Updated
    May 28, 2015
    Sponsor
    University of Campinas, Brazil
    Collaborators
    Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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    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

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