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

NCT05838469 | Unknown

• 1 other identifier: HUDHF-StripCrown
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Childhood Caries

Keywords

high viscosity glass ionomer cement; strip crown; pediatric dentistry; child; early childhood caries

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Strip Crown

EXPERIMENTAL

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

Interventions

Pediatric Strip Crown and High Viscosity Glass Ionomer Cement OTHER

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.

Strip Crown

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06100, Turkey (Türkiye)

Location

Related Publications (4)

• Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70.

  PMID: 25905657 BACKGROUND

• Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available.

  PMID: 27931421 BACKGROUND

• Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available.

  PMID: 32074851 BACKGROUND

• 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.

  PMID: 21840585 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: May 1, 2023
• Study Start: August 2, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)