Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth
Condition: Deep Caries
Study type: Interventional

Summary: 
      The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical
      trial was to evaluate the clinical, radiographic, and histopathological success of three
      different pulp-capping materials in one-stage indirect pulp treatment of primary teeth.

      The study included a total of 109 patients aged 5-9 years who had primary teeth with deep
      carious lesions with or symptoms of irreversible pulpitis. The teeth were divided into three
      groups according to the pulp-capping agents: (I) Calcium hydroxide (Ca[OH]2) (control group)
      (n=36), (II) bioactive tricalcium silicate (Biodentine) (n=37), and (III) resin-based
      tricalcium silicate (TheraCal LC) (n=36). All the teeth were evaluated clinically and
      radiographically at postoperative months 6, 12, 18, and 24. A total of 23 primary mandibular
      second molars that were in their regular exfoliation period (24-40 months) were extracted and
      fixed in 10% formaldehyde solution. The specimens were evaluated histologically to assess the
      integrity of the odontoblastic layer, tertiary dentin formation and the quality of the dentin
      formed, severity of pulpitis, and other pulpal changes.
    

Detailed description: 
      Following the clinical and radiographic examinations, pulp vitality was assessed with cold
      thermal test (Chloraethyl; Wehr, Baden, Germany) and electrical pulp test. After local
      anesthesia injection, rubber-dam isolation was performed. In the first step of the IPC
      procedure, cavity preparation was performed and the caries were removed using a high-speed
      dental handpiece with a diamond bur. In the second step, the carious peripheral dentin was
      removed at the enamel-dentin junction using a high-speed tungsten-carbide bur and the
      infected and necrotic soft dentin layer in the center was carefully removed to prevent pulp
      exposure. Cavity excavation was stopped when the residual dentin over the pulp tissue showed
      increased resistance to manual instrumentation, and the demineralized dentin (affected
      dentin) was left at the floor of the cavity.

      After this stage, the teeth were randomly divided into 3 groups:

      Ca(OH)2 Group (Control): The residual demineralized dentin was covered with a thin layer of
      Ca(OH)2 (Dycal; Dentsply/Caulk, Dentsply International Inc. Milford, DE, USA) in accordance
      with the recommendations of the manufacturer.

      Biodentine Group: A thin layer of tricalcium silicate-containing pulp-capping material
      (Biodentine, Septodont, France) consisting of powder and liquid was applied to the
      demineralized dentin tissue and a 12-min setting time was allowed for hardening, in
      accordance with the recommendations of the manufacturer.

      TheraCal LC Group: Flowable form of resin-reinforced tricalcium silicate-containing material
      (TheraCal LC, Bisco Inc, IL, ABD) was applied directly onto the demineralized dentin at a
      maximum thickness of 1 mm and was polymerized for 20 sec (Valo LED, Ultradent Products Inc.,
      South Jordan, USA), in accordance with the recommendations of the manufacturer.

      Afterwards, in all three groups, capsule glass ionomer cement (Capsule; GC Corporation,
      Tokyo, Japan, Corporation, Tokyo, Japan) was placed on each capping material. Following the
      etching and bonding process, permanent restoration was finished with composite resin (Filtek
      Z250 Universal Restorative System, 3M ESPE Dental products, USA).

      Histological examination A total of 23 primary mandibular second molars that were in their
      regular exfoliation period (in which the underlying permanent tooth germ had completed 2/3 of
      root formation) (24) and were found to be clinically and radiographically successful
      following IPC were extracted by the researcher and were processed for histological
      examination .All the extracted teeth were fixed in 10% formaldehyde solution. Three out of 23
      specimens were excluded from the study since they were unsuitable for sectioning.
    

Intervention name(s): Biodentine; TheraCal LC; Calcium hydroxide
Intervention type(s): Other; Other; Other
Intervention description(s): Biodentine has been shown to cause increased calcium ion release and this increase has been associated with the presence of pure tricalcium silicate and calcium chloride and the increased Ca(OH)2 formation; TheraCal LC (Bisco Inc, IL, USA) is a light-cured, resin-modified, calcium silicate-based material designed as a direct/indirect pulp-capping material. This agent has been shown to increase the pH on the pulpal surface thereby stimulating regenerative processes in the pulp, and ultimately contributing to the formation of dentin bridge; Calcium hydroxide (Ca[OH]2) is a successful pulp-capping agent activating the repair mechanism by stimulating the dentin-pulp complex. Ca(OH)2, with its bactericidal effects, protects the complex from bacterial effects and also has a stimulating effect on dentin remineralization
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, three-arm parallel, two-blinded clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: deep caries; indirect pulp capping