Viewing Study NCT02635867



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Last Modification Date: 2024-10-26 @ 11:54 AM
Study NCT ID: NCT02635867
Status: COMPLETED
Last Update Posted: 2023-10-12
First Post: 2015-12-08

Brief Title: Clinical Comparison of Vital Pulp Capping Restorative Protocols
Sponsor: University of Illinois at Chicago
Organization: University of Illinois at Chicago

Study Overview

Official Title: Clinical Comparison of Vital Pulp Capping Restorative Protocols A Randomized Controlled Double-Blind Prospective Study
Status: COMPLETED
Status Verified Date: 2022-12
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: At present dentistry aims for conservative treatments with the goal of maintaining as much tooth structure as possible Dental caries remains the most prevalent chronic disease worldwide these lesions can progress rapidly and reach deeper areas of the tooth The carious lesion is considered deep when it goes through the main tissues of the tooth and it can affect the pulp tissue where the nerve and nutrients of the tooth are located There are many treatment options for deep carious lesions and they vary by the clinical scenario Vital pulp therapy has become a fairly predictable alternative treatment to pulpectomy root canal therapy The goal of vital pulp capping therapies is to keep the pulp of the teeth vital to prevent further interventions such as root canal treatments and complex restorative work There are two main clinical scenarios when treating these lesions depending on the remaining dentin thickness between the carious lesion and the pulp vital direct and indirect pulp capping Direct and indirect vital pulp therapies are routinely performed using different clinical protocols The clinical protocols are selected based on the remaining dentin between the tooth preparation and pulp and the restorative materials There are few studies that evaluate pulp capping method in adult teeth permanent dentition many studies have investigated baby teeth deciduous teeth Routine therapies include the using of adhesive restorations with and without an intermediate layer of restorative material Calcium hydroxide based cements have been used for pulp capping as an intermediate layer of restorative material More recently a new intermediate layer of restorative material composed of resin-modified calcium silicate has been indicated for use on direct and indirect pulp capping The aims of this study are to compare over a period of 12 months the post-operative sensitivity and pulp vitality of three indirect pulp capping protocols and two direct pulp capping protocol in vital teeth This study will provide the necessary evidence to allow clinicians to select the best restorative protocol when treating deep carious lesions where indirect and direct pulp capping protocol are needed
Detailed Description: This randomized controlled double-blind prospective study compares over a period of 12 months the post-operative sensitivity and pulp vitality of three indirect pulp capping protocols TheraCal Bisco Dycal Caulk and no liner The study was approved by the University of Illinois internal review board Protocol 2014-1163 Potential subjects will be screened by one of 3 calibrated investigators through a brief interview and intraoral examination The screening process includes a medical and dental history demographics currentconcomitant medication oral soft and hard tissue examination 2 radiographs one periapical and one bitewing and a review of all inclusion and exclusion criteria The inclusion criteria consist of adults in good general health between 18 and 64 years of age with primary active carious lesions deep into the dentin 75 or more of carious dentin of permanent teeth absence of clinical symptoms of irreversible pulpitis spontaneous pain and lingering pain for more than 10 seconds after cold stimulus and absence of periapical pathology sinus tract swelling or abnormal mobility The outcomes measures are pain using visual analog pain scale pain assessment form and success rate pulp vitality based on percussion palpation cold test radiographic findings collected at the screening visit intervention day 24 hours 7 days 3 months 6 months and 12 months follow-up visits

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None