Clinical trial NCT03184012: Clinical Evaluation of Zirconia Crowns and Anterior Strip Crowns
Official title: Clinical Comparison Between Zirconia Crowns Versus Anterior Strip Crowns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: caries
full coverage
strip crown
Zirconia crown
primary anterior teeth
crown
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2017-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns
Primary purpose: TREATMENT

Brief summary: The hypothesis to be investigated is that no difference will be found upon comparing resin composite strip crowns and NuSmile zirconia crowns (NuSmile ZR) esthetic primary anterior in restoring anterior primary teeth.

Detailed description: The aim of this study is to clinically evaluate the performance of a new NuSmile ZR esthetic primary anterior crowns, compared with anterior resin composite strip crowns in the restoration of 120 teeth (primary incisors and lateral anterior teeth in the deciduous dentition of child patients).

Eligibility criteria: Inclusion Criteria:

* Healthy Children with no history of any systemic illness or any developmental disease of the teeth and jaws that would have affected dietary patterns, caries, susceptibility or the selection of restorative materials to the best of current knowledge.
* Minimal of two surfaces of caries in the targeted tooth.
* Patient with Early Childhood Caries as defined by American Academy of Pediatric Dentistry (AAPD), 2016.
* Cooperative patient who had behavioral rating "positive" or "definitely positive" followed the Frankl behavior classification scale. (Frankl et al. 1962)
* Opposing teeth present.
* Written consent was obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes, discomfort, risks, and benefits.
* No patient was excluded on the basis of gender, race, social or economic background.

Exclusion Criteria:

* Teeth with proximity to exfoliation and resorption of the root passed its half.
* Patients with allergy or hypersensitivity to nickel in case of posterior group teeth.
* Presence of single surface caries not involving the proximal surfaces.
* Teeth that has been subjected to trauma.
* Anxious, uncooperative patients who need to be treated under general anesthesia.
* Children who suffer from bruxism.
* Children with special needs.
* Presence of tooth wear on the opposing teeth (in case of anterior teeth), or absence of opposing.

Primary outcomes:
measure: Gingival Health
timeFrame: 3-month follow-up
measure: Plaque index
timeFrame: 3-month follow-up
measure: Restoration failure
timeFrame: 3-month follow-up
measure: Tooth wear of opposing dentition
timeFrame: 3-month follow-up
measure: Gingival Health
timeFrame: 6-month follow-up
measure: Plaque index
timeFrame: 6-month follow-up
measure: Restoration failure
timeFrame: 6-month follow-up
measure: Tooth wear of opposing dentition
timeFrame: 6-month follow-up
measure: Gingival Health
timeFrame: 12-month follow-up
measure: Plaque index
timeFrame: 12-month follow-up
measure: Restoration failure
timeFrame: 12-month follow-up
measure: Tooth wear of opposing dentition
timeFrame: 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: King Abdulaziz University
name: Bashaer S Abdulhadi, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alaki SM, Abdulhadi BS, AbdElBaki MA, Alamoudi NM. Comparing zirconia to anterior strip crowns in primary anterior teeth in children: a randomized clinical trial. BMC Oral Health. 2020 Nov 10;20(1):313. doi: 10.1186/s12903-020-01305-1.