Clinical Applicability of PBS® CIMMO Cement in Pulpotomies
Condition: Pulpotomy
Study type: Interventional

Summary: 
      Randomized clinical study in pulpotomies of deciduous molar teeth. A comparison of two
      techniques is established.
    

Detailed description: 
      This is a randomized controlled clinical trial conducted at the Universidade do Vale do
      Sapucaí (UNIVAS), Pouso Alegre, Minas Gerais and the University of Vale do Rio Verde
      (UNINCOR) Três Corações, Minas Gerais. A project will be submitted to the Brazil Platform to
      UNIVÁS and UNINCOR ethics committees. Thirty children aged four to ten years old will be
      selected from the Pediatric Dentistry Clinic of the College of Dentistry of the Vale do Rio
      Verde Três Corações University. The sample will consist of 30 primary molars that show
      indication for pulpotomy. The inclusion criteria of the teeth to be selected are: absence of
      spontaneous painful symptomatology in the preoperative period, evidence of live red bleeding,
      cut resistance, associated with hemostasis after exposure of the pulp tissue.
      Radiographically, the teeth should present 2/3 of the root length, absence of radiolucent
      inter-radicular lesion and internal root resorption.

      The technique recommended will be in a single session. Local anesthesia with 1: 100,000
      articaine (DFL®) will be used a tube containing 1.8 ml. Absolute insulation with clamp 14
      (IVORY®), rubber sheet (Madeitex®) and arch (JON®). The opening will be performed with a 1016
      HL (KG®) drill and a dentin curette (Duflex®). All carious tissue and the coronary pulp will
      be removed with abundant irrigation.

      In group A (control) the irrigation will be with physiological saline and then it will be
      applied in the pulp chamber with autoclaved cotton ball, formocresol for five minutes.
      Subsequently, calcium hydroxide cement base (Hidro C®), zinc oxide cement base and eugenol
      (IRM®) and restoration of the final tooth with composite resin will be inserted.

      In group B the irrigation will be with sterile distilled water (the cement to be used loses
      its properties in front of the saline solution). Excess blood and distilled water from the
      irrigation will be sucked through disposable endodontic cannula (DFL®) and the fast trapped
      PBS®CIMMO cement will be handled through sterile glass plate and spatula 24 (Duflex®). Then
      it will be taken to the humid chamber with cement door, old amalgam (Duflex®) and condenser
      with Schilder condenser number 5 (Odus®). The cement will serve as a sub-base, base and final
      restoration.

      Patients will be submitted to final radiographs and receive systemic medication with
      analgesic and anti-inflammatory. The evaluations will be carried out in 6 months and will be
      through clinical and radiographic examinations, to define the result of the treatments.
      Clinical examinations will be performed under artificial light through an exploratory probe
      (Duflex®) and clinical mirror (Duflex®). The clinical criteria to be observed are: edema,
      mobility, fistula and pain. The radiographic evaluations will be through periapical
      radiography with the aid of a radial ortho positioner (DFL®). In the radiographs will be
      observed the presence or absence of internal and external resorptions, as well as presence or
      absence of inter-radicular lesion.

      The statistical analysis will be through the chi-square test and the level of significance
      will be 5%.
    

Intervention name(s): formocresol and zinc oxide.; PBS CIMMO cement.
Intervention type(s): Device; Device
Intervention description(s): Removal of the coronary pulp from primary molar teeth, use of formocresol and zinc oxide; Removal of the coronary pulp from primary molar teeth, use of PBS cement
Other intervention name(s): Formocresol and zinc oxide technique; PBS CIMMO technique
Intervention MeSH terms: Zinc; Zinc Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparative study with same series for the two groups
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulpotomy; Biological cement; Deciduous tooth