Sodium Hypoclorite as an Antibacterial Agent Prior to Pulpotomies
Condition: Pulpotomy; Primary Teeth
Study type: Interventional

Summary: 
      Aim: The aim of this study was to report the 24-Month radiographical and histological outcome
      on these previously reported calcium hydroxide (CH) and mineral trioxide aggregate (MTA)
      pulpotomies using of five percent sodium hypochlorite (NaOCl) as an antibacterial agent to
      clean the chamber prior to application of the pulpotomy agent.

      Materials and Methods: 128 primary molars were randomly divided into two main groups
      according to pulpotomy material (CH/MTA) and into two sub-groups according to selected the
      antibacterial agent (NaOCl/physiologic saline) used in the pulpotomy procedure. After these
      procedures, teeth were followed radiographically for 24 months. Thirty-four successfully
      treated teeth whose successors roots had completed formation of at least two-thirds of their
      lengths were extracted for histological evaluation. Fisher's-exact test, Pearson's-chi-square
      test and MannWhitneyU test with Bonferroni correction were used for statistical analysis.
    

Detailed description: 
      The procedure and possible discomforts, risks, and benefits had been fully explained to the
      parents of the children, and informed consent forms were signed.

      A total of 64 children (37 boys and 27 girls), between six to 10 years old (mean=8.2 years
      old) who had at least two mandibular primary molars with nearly equal carious involvement
      that required pulpotomy were included in the study. Following anesthesia and rubber dam
      isolation, the pulpotomy procedure was realized. After amputation of the coronal pulp tissue,
      pulpal hemorrhage was controlled using dry sterile cotton pellets under slight pressure for
      approximately 5 min. Four teeth were excluded from the study because of uncontrolled
      bleeding.

      A total of 124 teeth were randomly distributed (by a coin toss) among groups representing
      different pulpotomy materials (CH or MTA) and cleansing agents (NaOCl or physiologic saline).

      CH pulpotomy (n = 62 teeth): After hemorrhage control, two teeth in each child were randomly
      assigned by the toss of a coin to receive two cleansing agents, the experimental disinfecting
      agent 5% NaOCl (Wizard, Rehber Chemistry, Istanbul, Turkey) or the physiologic saline. CH
      control (n = 31 teeth): Pulp chamber was cleansed with physiologic saline prior the CH
      pulpotomy. CH NaOCl (n = 31 teeth): Pulp chamber was cleansed with 5% NaOCl for 30 s prior
      the CH pulpotomy. Then, canal orifices were sealed with CH (Kalsin, Aktu, Izmir, Turkey)
      paste (CH powder mixed with physiologic saline). After the canal orifice dressing, the
      chamber was based with reinforced ZOE (IRM; Dentsply Caulk, Milford, DE) and the tooth
      immediately restored with a stainless steel crown (SSC; 3M ESPE, Seefeld, Germany).

      MTA pulpotomy (n = 62 teeth): As stated above, following the hemorrhage control, two
      cleansing agents were randomly applied to the cavity. MTA control (n= 31 teeth): Pulp chamber
      was cleansed with physiologic saline prior the MTA pulpotomy. MTA NaOCl (n = 31 teeth): Pulp
      chamber was cleansed with 5% NaOCl for 30 s prior the MTA pulpotomy. Then, canal orifices
      were sealed with MTA (ProRoot MTA; Dentsply, Tulsa, OK, USA) and a moistened cotton pellet
      was placed over the MTA paste to allow setting of the material. Reinforced ZOE was placed as
      a temporary restoration; the ZOE and the cotton pellets were removed after 24 h, and the
      teeth finally restored with SSCs.

      The treatments received follow-up evaluations every six months, for 24 months, following the
      completion of the treatments. One examiner, who was blinded to treatment type, evaluated the
      teeth clinically and radiographically. At follow-up appointments, clinical success was
      confirmed by the absence of spontaneous pain, pathologic mobility, tenderness to percussion,
      swelling, fistula, or gingival inflammation. Radiographic success was considered when
      internal/external root resorption and periapical/furcal radiolucency was not observed.
      Calcific metamorphosis of the pulp was not considered a failure. The data were analyzed using
      Fisher's exact, McNemar, and Pearson's chi-square tests with Bonferroni correction.

      Histological assessment Clinically and radiologically successful teeth -whose successors
      roots had completed formation of at least two thirds of their lengths- were extracted for
      histopathological evaluation. Following extraction, the teeth were immediately immersed in 10
      % buffered formalin, embedded in paraffin, and serially sectioned through the root canals in
      a mesiodistal direction using a microtome to obtain sections of 5 μm in thickness. Sections
      were stained using hematoxylin eosin and examined under a light microscope.
    

Intervention name(s): CH Pulpotomy, physiologic saline; CH pulpotomy, NaOCl; MTA Pulpotomy, physiologic saline; MTA pulpotomy, NaOCl
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Pulp chamber was cleansed with physiologic saline for 30 s.; Pulp chamber was cleansed with 5 % NaOCl for 30 s.; Pulp chamber was cleansed with physiologic saline for 30 s.; Pulp chamber was cleansed with 5 % NaOCl for 30 s.
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: calcium hydroxide; mineral trioxide aggregate; sodium hypochlorite