Clinical trial NCT03740308: Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth
Official title: Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Teeth
Keywords: Primary posterior teeth
zirconia crown
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 5
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to compare the clinical outcomes of two full-coronal-coverage restorations (locally-made preformed Zirconia crowns \[LMP\] and NuSmile Zirconia crowns \[Nu/ZR\]) in treating carious primary teeth. Amongst the children attending the clinics of the Dental School at Damascus University, the ones having an indication for crowns restorations will be screened and if they are conformant to the inclusion criteria then they will be recruited until 60 teeth are reached (30 teeth for LMP/ZR restorations and 30 for Nu/ZR restorations).

Detailed description: This randomized clinical trial compares the clinical outcomes of using two full-coronal zirconia restorations (locally-made preformed zirconia crowns, and NuSmile zirconia crowns) in treating carious primary teeth. Children attending to the clinics of the Faculty of Dentistry - Damascus University and who happen to be in need for dental restorations will be screened for the study's inclusion criteria till 60 teeth are recruited (30 teeth for locally made preformed zirconia crowns restorations and 30 for NuSmile zirconia crowns restorations). One crown only will be used for each patient (totally 60 patients) to ensure equalizing the variables for both groups. The randomization will be done using SPSS software version 20.0 (Armonk, NY; IBM Corp., USA). The study is going to be a double-blinded study (Patients blinding and Outcomes-assessor blinding). Simple descriptive statistics will be used for the analysis, also using Wilcoxon Signed-Rank test. The level of significance will be set at (α = 0.05) and the level of confidence at (95%). The intervention is preparing primary molars which have one or more indications for crowning, and according to manufacturer instructions. Then following up the treated primary molars for 1 month, 3 months, and 6 months intervals. The main goals are measuring and comparing the status of the gingiva and any improvements in the gingival health relative to the intervention, the plaque retention in regard to the gingival response to the material of restoration, and also the crowns resistance to changes, despite its high cost.

Eligibility criteria: Inclusion Criteria:

* Patients within the age group of 4 to 8 years of age.
* Patients with good oral hygiene.
* Healthy children, i.e. free of any systematic diseases or any developmental disturbances of the teeth and jaws
* A minimal of two surfaces of caries in the targeted tooth
* Corresponding treated teeth has not got any crown earlier
* Patients with ECC as defined by the American Academy for Pediatric Dentistry.
* Cooperative patients who have a dental behavioral assessment of "definitely positive" according to Frankl behavior classification scale.

Exclusion Criteria:

* No patient is excluded by gender, race, or due to socio-economic backgrounds.

Primary outcomes:
measure: Changes of crowns integrity
timeFrame: Evaluating after 1 month, 3 months, 6 months
Secondary outcomes:
measure: Changes of gingival index
timeFrame: Evaluating after 1 month, 3 months, 6 months
measure: Changes of crown marginal adaptation
timeFrame: Evaluating after 1 month, 3 months, 6 months
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
affiliation: Professor - Pediatric Dentistry Department - Faculty of Dentistry - Damascus University
name: Mohamed AlTinawi, PhD.
role: STUDY_DIRECTOR
References:
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citation: Shah PV, Lee JY, Wright JT. Clinical success and parental satisfaction with anterior preveneered primary stainless steel crowns. Pediatr Dent. 2004 Sep-Oct;26(5):391-5.