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Completed

NCT Number: NCT05462808

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

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.

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Key information

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Isparta, 32260, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High viscosity glass ionomer cement

Drug

High viscosity glass ionomer cement

Other names: EQUIA Forte (GC Corp., Leuven, BE)

Stainless steel crown

Device

Stainless steel crown

Other names: 3M ESPE, St. Paul, USA

Primary outcomes

  1. Hall technique

    Time frame: 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 outcomes

  1. Atraumatic restorative treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Esra Oz

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2021
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.