Clinical efficacy of different marginal forms of endocrowns: study protocol for a randomized controlled trial.

BACKGROUND

After root canal treatment, most tooth defects need to be restored. Onlay restoration is widely used to restore dental defects. Endocrown is a new type of onlay; however, dentists have yet to obtain a full understanding of the clinical effects of marginal forms of endocrowns. Here, we present a multicenter protocol to compare the clinical efficacy of two marginal forms (flat and 90-degree shoulder) for tooth restoration. The efficacy will be evaluated by marginal fit, marginal discoloration, and integrity of restoration.

METHODS

The proposed flat and 90-degree shoulder marginal endocrown assessment trial is an open-label, parallel-group, multicenter randomized controlled trial involving two hospitals. A total of 200 patients will be included in this trial, and the following patient inclusion criteria will be applied: good oral hygiene habits, no periodontal diseases, receipt of standard root canal treatment, and need for endocrown restoration. Patients will be enrolled after providing signed informed consent and will be divided into two groups (flat and 90-degree shoulder endocrown) in accordance with a random number table. Treatment allocation will be balanced (1:1). Endocrowns will be cemented by dual-cured luting composite. Clinical evaluations will be performed at baseline and at 24 months after treatment in accordance with modified US Public Health Service criteria by two independent evaluators. The primary outcome will be marginal fit; secondary outcome measures will include debonding, marginal discoloration, and integrity of restoration. All acquired data will be analyzed by an independent statistician. Wilcoxon one-sample tests will be used for intra-group comparisons, and Wilcoxon two-sample tests will be used for inter-group comparisons. The Bonferroni method will be used to correct for multiple comparisons, and hierarchical logistic regression will be applied to determine central effects.

DISCUSSION

The results of this trial will provide a clinical basis for clinicians to restore teeth by endocrowns and to improve long-term restoration for patients.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT03398395. Registered on 12 January 2018.