Pulpotomy Clinical Trial
Official title:
Clinical, Radiographic, and Histologic Outcome of Sodium Hypoclorite as an Antibacterial Agent Prior to Calcium Hydroxide and Mineral Trioxide Aggregate Pulpotomies in Primary Teeth
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.
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.
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