Clinical Comparison of Vital Pulp Capping Restorative Protocols
Condition: Deep Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

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,
      current/concomitant 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,
    

Intervention name(s): 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
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material; Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material; Use of a dental restorative protocol using resin-based dentin bonding system only; Use of a dental restorative protocol using Resin-modified calcium silicate - TheraCal pulp capping restorative material; \Use of a dental restorative protocol using Calcium hydroxide - Dycal pulp capping restorative material
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: vital pulp; reversible pulpitis; pulp capping; deep cavity; Management of Deep Dental Caries