Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth

Primary Teeth Clinical Trial

Official title:

Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740308
• Other study ID #: UDDS-Pedo-01-2018
• Status: Completed
• Phase: N/A
• Start date: May 17, 2018
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2020
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Primary Teeth

Intervention

Device:
• Locally Made Zirconia Crowns
Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. Locally Made Zirconia Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).
• ZR Zirconia Crwons NuSmile ® Crowns
Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. ZR Zirconia Crwons NuSmile ® Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (7)

Aiem E, Smaïl-Faugeron V, Muller-Bolla M. Aesthetic preformed paediatric crowns: systematic review. Int J Paediatr Dent. 2017 Jul;27(4):273-282. doi: 10.1111/ipd.12260. Epub 2016 Aug 17. Review. — View Citation

Croll TP, Helpin ML. Preformed resin-veneered stainless steel crowns for restoration of primary incisors. Quintessence Int. 1996 May;27(5):309-13. — View Citation

Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. — View Citation

Fuks AB, Ram D, Eidelman E. Clinical performance of esthetic posterior crowns in primary molars: a pilot study. Pediatr Dent. 1999 Nov-Dec;21(7):445-8. — View Citation

Mittal HC, Goyal A, Gauba K, Kapur A. Clinical Performance of Indirect Composite Onlays as Esthetic Alternative to Stainless Steel Crowns for Rehabilitation of a Large Carious Primary Molar. J Clin Pediatr Dent. 2016;40(5):345-52. doi: 10.17796/1053-4628- — View 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. — View Citation

Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of crowns integrity	Crowns integrity changes will be measured with the naked eye and the light cure device. The scores are as follows: (0 = No crack, No fracture, No chip) (1 = Chip) (2 = Crack) (3 = Fracture). (Cvar and Rygp 2005)	Evaluating after 1 month, 3 months, 6 months
Secondary	Changes of gingival index	is measured by passing the periodontal probe tip gently within the sulcus around each crowned tooth. The scores are as follows: (0 = normal gingiva) (1= mild inflammation) (2 = Moderate inflammation) (3 = severe inflammation). (Loe and Silness 1963)	Evaluating after 1 month, 3 months, 6 months
Secondary	Changes of crown marginal adaptation	Crown marginal adaptation will be measured at the buccal and lingual walls and will be referred to as either good for crowns with sealed margins or poor when the explorer detects an open margin. (Farsi and Sharaf 2004)	Evaluating after 1 month, 3 months, 6 months