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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05838469
Enrollment
100
Registered
2023-05-01
Start date
2022-08-02
Completion date
2024-08-31
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Childhood Caries

Keywords

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

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.

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.

Interventions

OTHERPediatric 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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline to 12 months regarding Anatomic formbaseline, 3-month, 6-month,12-monthalpha: 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
Change from baseline to 12 months regarding Marginal adaptationbaseline, 3-month, 6-month,12-monthalpha: 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
Change from baseline to 12 months regarding Surface roughnessbaseline, 3-month, 6-month,12-monthalpha: 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
Change from baseline to 12 months regarding Marginal stainingbaseline, 3-month, 6-month,12-monthalpha: 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
Change from baseline to 12 months regarding Retentionbaseline, 3-month, 6-month,12-monthalpha: intact bravo: chipped/loss of material charlie: complete loss of crown
Change from baseline to 12 months regarding Incisal wearbaseline, 3-month, 6-month,12-monthalpha: intact bravo: wear of occlusal surface without tooth surface exposure charlie: wear of occlusal surface with tooth surface exposure

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026