Viewing Study NCT02492841



Ignite Creation Date: 2024-05-06 @ 7:13 AM
Last Modification Date: 2024-10-26 @ 11:46 AM
Study NCT ID: NCT02492841
Status: COMPLETED
Last Update Posted: 2024-05-30
First Post: 2015-05-27

Brief Title: Calcium Hydroxide Mineral Trioxide Aggregate and Biodentine Trademark as Direct Pulp Capping of Permanent Teeth
Sponsor: Universidad de los Andes Chile
Organization: Universidad de los Andes Chile

Study Overview

Official Title: Controlled Clinical Trial of the Effect of Calcium Hydroxide Mineral Trioxide Aggregate MTA and Biodentine Trademark as Direct Pulp Capping Materials of Permanent Teeth Affected by Caries in Children From 7 to 16 Years
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Dental caries is considered an oral health problem worldwide In Chile the last national epidemiological study 2007 showed a national prevalence of dental caries in children 6 years 703 and 12 625 Direct pulp capping is a preventive dental therapy keeps the vitality of the tooth using some inductive materials mineralized tissue formation

Objective The main objective of this study is to evaluate the effectiveness of two innovative direct pulp capping materials Biodentine compared MTA and calcium hydroxide in the maintenance of pulp vitality in teeth permanent molars
Detailed Description: Methodology It is a randomized controlled study groups signed the informed consent for clinical trial patients a clinical evaluation of 90 permanent molars teeth through endodontic diagnostic tests and radiograph will be conducted to determine diagnosis Will be assigned randomly to the type of material to use and direct pulp teeth affected by caries coating is carried out Patients will not have knowledge of the material to be used in the coating The patient will be clinically evaluated at 1 week 3 months and 8 months and radiographically at the beginning and end of the study In each clinical control endodontic diagnostic tests of heat cold electric and percussion will be performed In radiographic controls take a radiograph control with positioner or surveyor at baseline and 8 months to evaluate the periapical status Clinical success will consider that tooth in continuous controls and after 8 months presented vitality and radiographic signs of apical image without injury Failure unresponsive to consider whether susceptibility testing of cold and electricity in more than one control and presents radiographic image with apical lesion

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
SA13I20175 OTHER_GRANT FONIS SA13I20175 None