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ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars

Sponsor
Esra Oz (Other)
Overall Status
Completed
CT.gov ID
NCT05462808
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
24.4
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary molars are the teeth with the highest caries tendency among primary teeth due to their anatomical features such as wide and flat interface areas. However, some difficulties are encountered during the removal of caries due to the structural features of primary molars and the young age of the child. Therefore, in the treatment of primary molars, Atraumatic Restorative Treatment (ART), in which the soft parts of the carious lesion are cleaned with the help of a sharp hand tool and restored with an adhesive glass ionomer cement (GIC) that releases fluoride, in the following years, the deciduous teeth were removed with a minimally invasive approach. Hall technique, in which a stainless steel crown (SSC) is placed without preparation for treatment, has come to the fore.

Condition or Disease Intervention/Treatment Phase
  • Drug: High viscosity glass ionomer cement
  • Device: Stainless steel crown
 Phase 2

Detailed Description

Many restorative materials, especially GIC, have been used for ART procedures, and with the advancing technology, high-viscosity glass ionomer cements with improved mechanical and chemical properties have emerged. In recent years, zinc-added HVGICs and nano-filled resin-modified HVGICs have been introduced.

The Hall Technique has been suggested in the treatment of asymptomatic decayed primary molars in anxious and fearful patients to ensure patient cooperation. In this technique, it is aimed to stop the progression of caries by covering the carious deciduous molars with SSC and cutting their relationship with the oral environment, without the need for local anesthesia and tooth preparation. Thus, as the bacteria cannot use the carbohydrates in the oral environment, the number of bacteria in the environment will also decrease.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
ART Restorations With High-viscosity Glass-ionomer Cement Versus Hall Technique in Primary Molars
Actual Study Start Date :
Mar 20, 2019
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
Apr 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement

Under cotton roll isolation, teeth were restored with EQUIA Forte cement. A layer of EQUIA Forte Coat was applied with a microbrush on surface and then light cured for 20 s

Drug: High viscosity glass ionomer cement
High viscosity glass ionomer cement
Other Names:
  • EQUIA Forte (GC Corp., Leuven, BE)

    		•
    Experimental: restorations with Hall technique

    In the Hall technique group, the deposits on the occlusal surface of the teeth were gently removed, SSC (3M ESPE, St. Paul, USA) was placed and were cemented using GIC. The crown was pressed tightly.

    Device: Stainless steel crown
    Stainless steel crown
    Other Names:
  • 3M ESPE, St. Paul, USA

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Hall technique [up to 18 months]

      The restorations were scored as Alpha (A), clinically ideal restoration ''successful''; Bravo (B), clinically ''acceptable''; Charlie (C), clinically unacceptable restoration ''unsuccessful''. Outcomes criteria for assessment of the Hall Technique were made according to Innes et al.

    Secondary Outcome Measures

    1. Atraumatic restorative treatment [up to 18 months]

      Clinical evaluations of teeth treated with ART using EQUIA Forte were performed according to the modified USPHS criteria established by a modification of the United States Public Health Service (USPHS) clinical evaluation criteria.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 7 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • children with no systemic disease,

    • children who had a Frankl Behavioral Scale score 2,

    • children who have no occlusal problems or bad habits,

    • children presenting between 2-5 caries lesion in primary molars.

    Exclusion Criteria:

    • teeth with presence of radyolusens in furcation and/or periradicular areas,

    • teeth with pathologic resorption and internal/external resorption

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department Isparta Turkey 32260

    Sponsors and Collaborators

    • Esra Oz

    Investigators

    • Study Director: Esra Oz, Suleyman Demirel University Pediatric Dentistry

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Esra Oz, Pediatric department, Suleyman Demirel University
    ClinicalTrials.gov Identifier:
    NCT05462808
    Other Study ID Numbers:
    • 2014/157
    First Posted:
    Jul 18, 2022
    Last Update Posted:
    Jul 18, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jul 18, 2022