The ethical approval for our study has been obtained from the Clinical Research Ethics
Committee of Sivas Cumhuriyet University. The experimental phase of the study will be
conducted at the Department of Endodontics, Faculty of Dentistry, Sivas Cumhuriyet
University.
Patient Selection Criteria:
Participants aged between 18 and 45, who present with findings of irreversible pulpitis
in the lower first molar tooth and apply to the Department of Endodontics, Faculty of
Dentistry, Sivas Cumhuriyet University, will be included in the study.
In this study:
When α=0.05, β=0.10, and 1-β=0.90 were set, it was decided to include 17 teeth in each
group, and the power of the test was found to be p=0.90948.
Statistical Method:
The data obtained from our study will be recorded in the SPSS 22.0 program. When the
assumptions for parametric tests (Shapiro-Wilk) are met, one-way ANOVA will be used to
compare measurements obtained from two or more independent groups. If differences are
found, a Tukey test will be performed to determine which groups differ. If the parametric
assumptions are not met, the Kruskal-Wallis test will be applied, and the Mann-Whitney U
test will be used to identify the differing groups. The data will be presented in tables,
including arithmetic mean, standard deviation, median, minimum-maximum values, and the
error level will be set at 0.05.
Inclusion Criteria for the Study:
Age between 18 and 45 years, Absence of systemic disease, Apical periodontitis findings
may be present or not, Symptoms of irreversible pulpitis must be present, The apex of the
tooth must be closed, Pulp sensitivity tests (cold test and electric pulp test) must
respond positively, Periodontal pocket depth and mobility must be within normal limits,
Rubber dam isolation must be provided for the tooth to be treated, Restorative treatment
of the tooth must be possible, The patient's mouth opening must be sufficient.
Exclusion Criteria from the Study:
Presence of any systemic disease (including conditions requiring prophylaxis), Presence
of mental or psychiatric disorders, Presence of any allergic condition, Use of
painkillers in the last 12 hours before the procedure or antibiotics in the last week,
Loss of tooth structure that cannot be restoratively treated, Presence of a fistula tract
or abscess, Negative response to pulp sensitivity tests (cold test and electric pulp
test), No bleeding in the pulp or failure to achieve hemostasis within 6 minutes after
total pulpotomy, Open apex, Advanced canal calcification observed on periapical
radiography, Presence of internal or external root resorption.
After clinical and radiographic examinations, pulpal and periapical diagnosis will be
established before the procedure. A diagnostic periapical radiograph will be taken using
a film holder with the parallel technique to visualize the depth of the carious lesion
and evaluate the periapical area. All patients will be informed about treatment details,
materials used, possible complications, follow-up dates, and alternative treatment
options. A written consent form will be obtained from patients indicating alternative
options for root canal treatment, tooth extraction, or withdrawal from treatment. Prior
to treatment, the pre-operative pain values of participants will be recorded. The
pulpotomy procedure will be carried out according to the following protocol:
Anesthesia : Anesthesia will be provided using 4% articaine with 1:100,000 epinephrine.
The tooth will be isolated with a rubber dam. The tooth designated for pulpotomy will be
disinfected using 5% NaOCl before the procedure. After cleaning the caries, the exposed
coronal pulp tissue will be amputated to the level of the canal orifices using a
high-speed sterile diamond bur. Pulp vitality will be assessed visually by checking for
bleeding at each canal orifice. Hemostasis will be achieved by applying gentle pressure
with a cotton pellet soaked in 2.5% NaOCl for 2 minutes, and this will be repeated up to
three times (for a total of 6 minutes) if necessary.
After achieving hemostasis, the pulp capping material will be randomly selected from
ProRoot MTA (Denstply), Biodentin (Septodont), or TheraCal PT (ThPT, Bisco Inc) using
www.randomizer.org. The application of materials will be performed according to the
manufacturer's instructions.
Applications:
ProRoot MTA Application :
Coronal pulp tissue will be removed using a high-speed sterile diamond bur. Then,
hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in
2.5 % NaOCl for 2 minutes, and this will be repeated up to three times (totaling 6
minutes) if necessary. After confirming bleeding control, the ProRoot MTA material will
be placed at the canal openings. After a waiting period of 15 minutes, a thin layer of
Resin Modified Glass Ionomer Cement (Vitrebond, 3M; ESPE) will be applied as the base
material. Finally, the tooth will receive restorative treatment to complete the
procedure.
Biodentin Application :
Coronal pulp tissue will be removed using a high-speed sterile diamond bur, and
hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in
2.5% NaOCl for 2 minutes, repeated up to three times (totaling 6 minutes) if necessary.
After confirming bleeding control, the Biodentin material will be placed at the canal
orifices. According to the manufacturer's instructions, after a waiting period of 12
minutes, a thin layer of Resin Modified Glass Ionomer Cement (Vitrebond, 3M; ESPE) will
be applied as the base material. Finally, the tooth will receive restorative treatment to
complete the procedure.
TheraCal PT Application :
After the coronal pulp tissue is removed using a high-speed sterile diamond bur,
hemostasis will be achieved by applying gentle pressure with a cotton pellet soaked in
2.5% NaOCl for 2 minutes, and this will be repeated up to three times (totaling 6
minutes) if necessary. After confirming bleeding control, the TheraCal PT material will
be placed. Following a 10-second irradiation period according to the manufacturer's
instructions, a thin layer of Resin Modified Glass Ionomer Cement (Vitrebond, 3M; ESPE)
will be applied as the base material. Finally, the tooth will receive restorative
treatment to complete the procedure.
Monitoring and Pain Assessment:
After the treatment, participants will be asked to fill out the Visual Analog Scale (VAS)
chart to determine the severity of pain. Participants will be instructed to indicate
their pain intensity at that moment on the VAS chart, marking between 0-100 mm, for the
6th hour, 24th hour, 48th hour, 72nd hour, and 7th day. Participants will be contacted in
person or by phone for reminders over a 7-day period regarding when to fill out the form.
At the end of the week, participants will be asked to return to the clinic with their VAS
charts for a follow-up visit.
