Clinical trial NCT05838469: Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
Official title: Clinical Evaluation of High Viscosity Glass Ionomer Strip Crowns in Primary Maxillary Incisors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Early Childhood Caries
Keywords: high viscosity glass ionomer cement
strip crown
pediatric dentistry
child
early childhood caries
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline to 12 months regarding "Anatomic form"
timeFrame: baseline, 3-month, 6-month,12-month
measure: Change from baseline to 12 months regarding "Marginal adaptation"
timeFrame: baseline, 3-month, 6-month,12-month
measure: Change from baseline to 12 months regarding "Surface roughness"
timeFrame: baseline, 3-month, 6-month,12-month
measure: Change from baseline to 12 months regarding "Marginal staining"
timeFrame: baseline, 3-month, 6-month,12-month
measure: Change from baseline to 12 months regarding "Retention"
timeFrame: baseline, 3-month, 6-month,12-month
measure: Change from baseline to 12 months regarding "Incisal wear"
timeFrame: baseline, 3-month, 6-month,12-month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
state: Altındağ
Study officials:
References:
citation: Waggoner WF. Restoring primary anterior teeth: updated for 2014. Pediatr Dent. 2015 Mar-Apr;37(2):163-70.
citation: Policy on Early Childhood Caries (ECC): Unique Challenges and Treatment Options. Pediatr Dent. 2016 Oct;38(6):55-56. No abstract available.
citation: Policy on Interim Therapeutic Restorations (ITR). Pediatr Dent. 2018 Oct 15;40(6):58-59. No abstract available.
citation: 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.