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.

Study Overview

• Status: Completed
• Conditions: Primary Teeth Retained
• Intervention / Treatment: Drug: High viscosity glass ionomer cement; Device: Stainless steel crown

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Turkey
  • Isparta, Turkey, 32260
    • Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hall technique	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.	up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atraumatic restorative treatment	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.	up to 18 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2014/157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No