Dental Caries
Conditions
Keywords
caries, full coverage, strip crown, Zirconia crown, primary anterior teeth, crown
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).
Interventions
DEVICENuSmile Zirconia crowns by NuSmile company
anterior carious teeth restored with Zirconia crowns
DEVICEComposite resin strip crowns by 3M company
anterior carious teeth restored with Strip crowns
Sponsors
King Abdulaziz University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
one group assigned to be treated with Zirconia crowns, the other group assigned to be treated with resin composite strip crowns
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Health | 3-month follow-up | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index \[Löe, 1967\]. |
| Plaque index | 3-month follow-up | This parameter was evaluated using a blunt periodontal probe (Double ended probe Williams 1-2-3-5-7-8-9-10 Goldman Fox Flat) according to the Löe and Silness gingival index \[Löe,1967\]. |
| Restoration failure | 3-month follow-up | This was clinically evaluated with visual assessment of the restoration, according to the US Public Health Service USPHS, Alpha criteria rating system \[Ryge, 1980\]. |
| Tooth wear of opposing dentition | 3-month follow-up | Tooth wear was evaluated according to the Smith and Knight Tooth Wear Index (Bardsley, 2008; Smith and Knight, 1984) |
Outcome results
None listed