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Trial record 64 of 1201 for:    tooth decay

Glass-ionomer Cement Containing Chlorhexidine for ART

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ClinicalTrials.gov Identifier: NCT02459730
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : June 2, 2015
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Aline R F de Castilho, University of Campinas, Brazil

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).

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: ART with GIC containing 1.25% CHX. Procedure: ART with GIC. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Glass-ionomer Cement Containing Chlorhexidine for ART
Study Start Date : February 2013
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2014


Arm Intervention/treatment
Experimental: ART with GIC containing 1.25% CHX
The cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).
Procedure: ART with GIC containing 1.25% CHX.
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).

Active Comparator: ART with GIC
The cavities were filled with the press finger technique using KetacMolar Easymix® (control group).
Procedure: ART with GIC.
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 Measures :
  1. Clinical long-term effect - Survival Rate [ Time Frame: up to 1 year after restorative procedure ]
    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 :
  1. Microbiological long-term effect (microbiological assessment of mutans streptococci (MS) counts) [ Time Frame: up to 1 year after restorative procedure ]
    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.



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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Responsible Party: Aline R F de Castilho, Postdoctoral scholar, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02459730     History of Changes
Other Study ID Numbers: GICCHXART
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by Aline R F de Castilho, University of Campinas, Brazil:
Dental caries
glass ionomer cement
ART

Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents