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Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors

H

Hacettepe University

Status

Active, not recruiting

Conditions

Early Childhood Caries

Treatments

Other: Pediatric Strip Crown and High Viscosity Glass Ionomer Cement

Study type

Interventional

Funder types

Other

Identifiers

NCT05838469
HUDHF-StripCrown

Details and patient eligibility

About

The aim of this study was to evaluate the clinical success of modified celluloid strip crown restorations applied using interim therapeutic restoration and high-viscosity glass ionomer cement to the maxillary anterior teeth of children with early childhood caries and cooperation problems.

Full description

Following the decision on the appropriate size of celluloid strip crown, the tooth will be isolated using roll cottons and the "cavity conditioner" (GC, Japan) will be applied to all surfaces for 10 seconds, washed away and dried with cotton pellets. The selected celluloid strip crown will be filled with a fluoride-releasing bulk fill hybrid glass ionomer cement (EQUIA Forte, GC, Japan) prepared by mixing for 10 seconds in an automatic mixer and placed on the tooth with light pressure. The excess material on the crown margins will be removed with a hand instrument, and the celluloid strip crown will be removed from the tooth. If necessary, the restoration will be polished using a polishing discs. After the crown surface is washed and dried, a nano-filled surface sealant (EQUIA Forte Coat, GC, Tokyo, Japan) will be applied for 10 seconds with a micro-tipped applicator and light cured for 20 seconds. Clinical evaluations will be done at the 3rd, 6th and 12th months.

Enrollment

100 estimated patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Read the informed consent form and agree to participate in the study
  • Healthy children, aged 2-6 years
  • Presenting at least one primary anterior tooth with a class I, II, IV or V caries lesion

Exclusion criteria

  • Uncooperative children
  • The need for vital or non-vital endodontic treatment in the primary tooth to be treated
  • Previously restorated tooth
  • Presence of bruxism, Class III occlusion or deep bite

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Strip Crown
Experimental group
Description:
This is a single-arm study. High viscosity glass ionomer strip crowns will be performed to all patients.
Treatment:
Other: Pediatric Strip Crown and High Viscosity Glass Ionomer Cement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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