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

NCT ID: NCT05462808

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-20

Study Completion Date

2021-04-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Primary Teeth Retained

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

High viscosity glass ionomer cement

Intervention Type DRUG

High viscosity glass ionomer cement

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.

Group Type EXPERIMENTAL

Stainless steel crown

Intervention Type DEVICE

Stainless steel crown

Interventions

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High viscosity glass ionomer cement

High viscosity glass ionomer cement

Intervention Type DRUG

Stainless steel crown

Stainless steel crown

Intervention Type DEVICE

Other Intervention Names

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EQUIA Forte (GC Corp., Leuven, BE) 3M ESPE, St. Paul, USA

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Esra Oz

OTHER

Sponsor Role lead

Responsible Party

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Esra Oz

Pediatric department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Esra Oz

Role: STUDY_DIRECTOR

Suleyman Demirel University Pediatric Dentistry

Locations

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Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Isparta, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2014/157

Identifier Type: -

Identifier Source: org_study_id

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