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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Early Childhood Caries
• Intervention / Treatment: Other: Pediatric Strip Crown and High Viscosity Glass Ionomer Cement

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Altındağ
    • Ankara, Altındağ, Turkey, 06100
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Strip Crown; This is a single-arm study. High viscosity glass ionomer strip crowns will be performed to all patients.

Other: Pediatric Strip Crown and High Viscosity Glass Ionomer Cement; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline to 12 months regarding "Anatomic form"	alpha: The general contour of the restorations follows the contour bravo: the general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does	baseline, 3-month, 6-month,12-month
Change from baseline to 12 months regarding "Marginal adaptation"	alpha: Explorer does not catch or has one-way catch when drawn across the restoration/tooth interface bravo: explorer falls into crevice drawn across the restoration/tooth interface charlie: Dentin or base is exposed along the margin bravo: The general contour of the restoration does not follow the contour of the tooth charlie: The restoration has an overhang does	baseline, 3-month, 6-month,12-month
Change from baseline to 12 months regarding "Surface roughness"	alpha: the surface of the restoration does not have any surface defects bravo: the surface of the restoration has minimal surface defects charlie: the surface of the restoration has severe surface defects	baseline, 3-month, 6-month,12-month
Change from baseline to 12 months regarding "Marginal staining"	alpha: there is no discoloration between the restorations and tooth bravo: there is discoloration on less than half of the circumferential margin charlie: there is discoloration on more than half of the circumferential margin	baseline, 3-month, 6-month,12-month
Change from baseline to 12 months regarding "Retention"	alpha: intact bravo: chipped/loss of material charlie: complete loss of crown	baseline, 3-month, 6-month,12-month
Change from baseline to 12 months regarding "Incisal wear"	alpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure	baseline, 3-month, 6-month,12-month

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• Friedl K, Hiller KA, Friedl KH. Clinical performance of a new glass ionomer based restoration system: a retrospective cohort study. Dent Mater. 2011 Oct;27(10):1031-7. doi: 10.1016/j.dental.2011.07.004. Epub 2011 Aug 15.
• Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70.
• Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available.
• Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: April 10, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: child; early childhood caries; pediatric dentistry; strip crown; high viscosity glass ionomer cement
• Other Study ID Numbers: HUDHF-StripCrown

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