NCT02635867

Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study

Completed NA Results posted Last updated 9 December 2022

What this trial tests

NA trial testing Indirect Pulp capping-Resin-modified calcium silicate - TheraCal in Deep Dental Caries in 109 participants. Completed in 1 August 2019.

Timeline

1 June 2015

Primary endpoint
1 July 2019

1 August 2019

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	109
Start date	1 June 2015
Primary completion	1 July 2019
Estimated completion	1 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Indirect Pulp capping-Resin-modified calcium silicate - TheraCal
• Indirect Pulp capping-Calcium hydroxide - Dycal
• Indirect Pulp capping-Resin-based dentin bonding agent
• Direct Pulp capping-Resin-modified calcium silicate - TheraCal
• Direct Pulp capping-Calcium hydroxide - Dycal

Conditions studied

• Deep Dental Caries — all drugs for Deep Dental Caries →

Sponsor

University of Illinois at Chicago

Who can join

Adults 18 to 64, any sex, with Deep Dental Caries. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Success Rate Based on Pulp Vitality Tests (Vital/Non Vital)
  Time frame: 12 months
  The success rate was based on 3 measures of pulp vitality that resulted in a diagnosis of vital or nonvital after 12-month follow-up: Vital: (1) palpation ="negative" response. (2) percussion = "negative" response. (3) response to cold stimuli= positive \[response time (seconds). Non vital: (1) palpation ="positive" response. (2) percussion = "positive"" response. (3) response to cold stimuli= p
• Pain Assessment Using Visual Analog Pain Scale (VAS) Scale.
  Time frame: 12 months
  All the subjects will be asked to answer one question tracing a line on a hard copy visual analogue scale within a centimeters scale (0-10 cm) The measurement was quantitative (cm). The subject is asked to rate the level of pain by drawing a line in a 10 cm line, 0 being no pain, 10 being the worst pain.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.