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Clinical Comparison of Vital Pulp Capping Restorative Protocols

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ClinicalTrials.gov Identifier: NCT02635867
Recruitment Status : Recruiting
First Posted : December 21, 2015
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Ana Bedran-Russo, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Deep Dental Caries Drug: Resin-modified calcium silicate - TheraCal LC Drug: Calcium hydroxide - Dycal Drug: Resin-based dentin bonding agent Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
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 : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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)].

  2. 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).

  3. 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.

  4. 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)



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Clinical inclusion criteria:

  • Adults in good general health between 18 and 64 years of age;
  • Active carious lesions deep into dentin (75% or more of dentin) involving occlusal/incisal and/or proximal surfaces of permanent teeth;
  • Absence of clinical symptoms of irreversible pulpitis (spontaneous pain);
  • Absence of periapical pathology, sinus tract, swelling or abnormal mobility;
  • Restorable teeth.

Radiographic inclusion criteria:

  • Extension of carious lesion close to potential exposure upon excavation (within the D3 region - lesion extending 2/3 within dentin); with the presence of a well-defined radiodense zone between the lesion and the pulp;
  • Absence of periapical radiolucency;
  • Absence of thickening of the periodontal ligament PDL;
  • Absence of resorptive defects.

Exclusion Criteria:

  • Non restorable teeth;
  • Teeth with:
  • Recent trauma (within 6 months);
  • Calcified root canals;
  • Periapical radiolucency;
  • Patients experiencing spontaneous moderate to severe pain;
  • Patients that are pregnant or planning to become pregnant in the next year.
  • Patients taking analgesics, anti-inflammatory, or antidepressant medications;
  • Patients with orthodontic treatment;
  • Newly erupted teeth.

Information from the National Library of Medicine

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


Locations
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    dentpulp@uic.edu   
Sponsors and Collaborators
University of Illinois at Chicago

Responsible Party: Ana Bedran-Russo, Associate Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02635867     History of Changes
Other Study ID Numbers: 2014-1163
First Posted: December 21, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by Ana Bedran-Russo, University of Illinois at Chicago:
vital pulp
reversible pulpitis
pulp capping
deep cavity
Management of Deep Dental Caries

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs