Deep Caries Clinical Trial
Official title:
Clinical, Radiographic and Histological Evaluation of Three Different Pulp Capping Materials in Indirect Pulp Treatment of Primary Teeth: A Randomized Clinical Trial
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.
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.
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