Preformed pediatric zirconia crown versus preformed pediatric metal crown: study protocol for a randomized clinical trial
Bibliographic record
Abstract
BACKGROUND: Guidelines in pediatric restorative dentistry recommend the use of preformed pediatric stainless steel crowns (SSCs) in cases of severe tooth decay of at least two surfaces. This clinically effective and safe restorative option is frequently refused by parents for esthetic reasons; they prefer conventional restorations using esthetic filling materials (composites, glass ionomer) if lesion severity limited to two surfaces permits. Recently, manufacturers have proposed esthetic preformed pediatric zirconia crowns (ZCs) but these have been assessed in only two randomized clinical trials (RCT) with follow-ups of 6 and 12 months. Only one of these RCTs was carried out on primary molars to test ZCs (NuSmile ZR) without a groove in its inner surface. The primary objective of this proposed RCT is to assess the effectiveness of ZCs compared with SSCs. Our hypothesis is that the effectiveness of ZCs will be equivalent to that of SSCs. METHODS: In this split-mouth, 2-year RCT, pairs of primary molars in 101 child participants will be randomized and restored with SSCs (ESPE, 3M) and ZCs (EZCrowns, Sprig Oral Health Technologies) characterized by grooves on their inner surface. Primary molars will first be allocated to SSCs, and 1 to 2 weeks later the other primary molar of the same pair will be restored by ZC. The primary outcome is the success defined by the "absence of major clinical and radiographic failure" (e.g., pain, pulp infection, dental abscess or periradicular pathology visible on radiographs). The secondary outcomes include the retention and fracture rates, the gingival condition, the wear of the antagonist of the treated teeth, as well as both parental and child satisfaction. DISCUSSION: This study will investigate two types of preformed pediatric crowns for the management of severe decay on primary molars. The results may help practitioners choose the better therapeutic option and to explain to parents the advantages and disadvantages of these two therapies. TRIAL REGISTRATION: NCT03296709 . Registered on 27 September 2017.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.027 | 0.032 |
| Meta-epidemiology (narrow) | 0.008 | 0.003 |
| Meta-epidemiology (broad) | 0.014 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.003 | 0.004 |
| Scholarly communication | 0.004 | 0.004 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.008 | 0.007 |
| Insufficient payload (model declined to judge) | 0.076 | 0.011 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".