Clinical Comparison of Vital Pulp Capping Restorative Protocols
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02635867|
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment|
|Deep Dental Caries||Drug: Resin-modified calcium silicate - TheraCal LC Drug: Calcium hydroxide - Dycal Drug: Resin-based dentin bonding agent|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Clinical Comparison of Vital Pulp Capping Restorative Protocols: A Randomized Controlled Double-Blind, Prospective Study|
|Actual Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2017|
Active Comparator: Indirect pulp capping therapy
Resin-modified calcium silicate - TheraCal LC Calcium hydroxide - Dycal Resin-based dentin bonding agent
|Drug: Resin-modified calcium silicate - TheraCal LC Drug: Calcium hydroxide - Dycal Drug: Resin-based dentin bonding agent|
Active Comparator: Direct pulp capping therapy
Resin-modified calcium silicate - TheraCal LC Calcium hydroxide - Dycal
|Drug: Resin-modified calcium silicate - TheraCal LC Drug: Calcium hydroxide - Dycal|
- Pulp Vitality Tests [ Time Frame: 12 months ]Assessment of pulp vitality will use three measurements: (1) palpation - "positive" or "negative" response; percussion - "positive" or "negative" response, and response to cold stimuli [response time (seconds) and lingering (seconds)].
- Pain assessment using 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 which will range from 0 to 10 (0 = no pain / 10 = pain as bad as could be).
- Radiographic assessment [ Time Frame: 12 months ]The criteria used to determine a successful radiographic outcome are: absence of interradicular or periapical radiolucencies, absence of increased PDL space and absence of resorptive defects.
- Radiographic research data collection [ Time Frame: 12 months ]An attempt will be made to assess changes to the remaining dentin thickness between recall appointments. Measurement will be made using digital tootl to quantify the remaining dentin thickness (mm)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635867
|United States, Illinois|
|University of Illinois at Chicago College of Dentistry||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Lina Saleh Hassan, BDS, MPH 312-996-1553 email@example.com|