Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-24 @ 5:05 PM
NCT ID:
NCT04271150
Brief Summary:
The purpose of this study is to evaluate and compare the clinical performance of a Universal adhesive's different application modes.
Detailed Description:
Class 2 composite restorations will be placed using a bulk-fill composite resin restorative on two posterior teeth with proximal caries, in a split mouth design. 25 patients will be included in the study. The teeth will be randomized into two groups according to the application mode of universal adhesive material.
Group 1: the universal adhesive will be used in etch-and-rinse mode Group 2: the universal adhesive will be used in self-etch mode. The US Public Health Service criteria (secondary caries, anatomical form, surface roughness, marginal integrity, marginal discoloration and retention) will be used for clinical evaluation of atraumatic resin restorations. The restorations will be evaluated at baseline and 6th, 12th, 18th, 24th months. Intra-oral photos will be taken directly after treatment and at control appointments to evaluate discoloration and seconder caries under magnification.
The data will be analysed statistically using Fisher's Exact Test; and the Kaplan-Meier and Wilcoxon method will be used to estimate survival percentages.
Study:
NCT04271150
Study Brief:
Protocol Section:
NCT04271150