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

NCT05462808 | Completed Phase 2

• 1 other identifier: 2014/157
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Teeth Retained

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Atraumatic restorative treatment

  up to 18 months

Study Arms (2)

Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement

EXPERIMENTAL

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

restorations with Hall technique

EXPERIMENTAL

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

Interventions

High viscosity glass ionomer cement DRUG

High viscosity glass ionomer cement

Also known as: EQUIA Forte (GC Corp., Leuven, BE)

Atraumatic Restorative Treatment restorations with high-viscosity glass ionomer cement

Stainless steel crown DEVICE

Stainless steel crown

Also known as: 3M ESPE, St. Paul, USA

restorations with Hall technique

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• teeth with presence of radyolusens in furcation and/or periradicular areas,
• teeth with pathologic resorption and internal/external resorption

Sponsors & Collaborators

• Esra Oz: lead

Study Sites (1)

Suleyman Demirel University Faculty of Dentistry Pediatric Dentistry Department

Isparta, 32260, Turkey (Türkiye)

Location

Study Officials

• Esra Oz

  Suleyman Demirel University Pediatric Dentistry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Pediatric department

Study Record Dates

• First Submitted: July 4, 2022
• First Posted: July 18, 2022
• Study Start: March 20, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)