Clinical Trial: Calcium Hydroxide, Mineral Trioxide Aggregate and Biodentine (Trademark) as Direct Pulp Capping of Permanent Teeth

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Chi

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 (70.3%) and 12 (62.5%). 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 Summary: 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.
Sponsor: Universidad Los Andes, Chile

Current Primary Outcome: pulp diagnosis [ Time Frame: 6 months ]

vitality test with electric device cold and hot test radiographic evaluation


Original Primary Outcome: Same as current

Current Secondary Outcome: testing treatment [ Time Frame: 1 week, 3 and 6 months ]

dental pulp vitality test radiographic


Original Secondary Outcome: Same as current

Information By: Universidad Los Andes, Chile

Dates:
Date Received: May 27, 2015
Date Started: April 2014
Date Completion: May 2016
Last Updated: July 6, 2015
Last Verified: July 2015