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

NCT03740308 | Completed DMC

• 1 other identifier: UDDS-Pedo-01-2018
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Teeth

Keywords

Primary posterior teeth; zirconia crown

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes of gingival index

  Evaluating after 1 month, 3 months, 6 months

• Changes of crown marginal adaptation

  Evaluating after 1 month, 3 months, 6 months

Study Arms (2)

Locally Made Zirconia Crowns

ACTIVE COMPARATOR

One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions.

Device: Locally Made Zirconia Crowns

ZR Zirconia Crwons NuSmile ® Crowns

EXPERIMENTAL

One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. (Same as Arm 1 Description)

Device: ZR Zirconia Crwons NuSmile ® Crowns

Interventions

Locally Made Zirconia Crowns DEVICE

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).

Locally Made Zirconia Crowns

ZR Zirconia Crwons NuSmile ® Crowns DEVICE

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).

ZR Zirconia Crwons NuSmile ® Crowns

Eligibility Criteria

• Age: 5 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related Publications (7)

• Aiem E, Smail-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.

  PMID: 27532506 RESULT

• 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. doi: 10.1007/s00784-005-0018-z. No abstract available.

  PMID: 16315023 RESULT

• 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.

  PMID: 10633519 RESULT

• Sharaf AA, Farsi NM. A clinical and radiographic evaluation of stainless steel crowns for primary molars. J Dent. 2004 Jan;32(1):27-33. doi: 10.1016/s0300-5712(03)00136-2.

  PMID: 14659715 RESULT

• 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: 10.17796/1053-4628-40.5.345.

  PMID: 27617373 RESULT

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

  PMID: 8941812 RESULT

• 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.

  PMID: 15460292 RESULT

Study Officials

• Mohamed AlTinawi, PhD.

  Professor - Pediatric Dentistry Department - Faculty of Dentistry - Damascus University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blinded study (Patients blinding \& Outcome-assessor blinding).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: November 14, 2018
• Study Start: May 17, 2018
• Primary Completion: December 1, 2018
• Study Completion: August 1, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)