Impact of TruNatomy and ProTaper Gold Ni-Ti Systems Using Resin-based or Bioceramic Sealers on Postoperative Pain After Root Canal Treatment: a Randomized Clinical Trial
Phase: NA
Conditions: Irriversible Pulpitis
Sponsor: European University of Lefke

Clinical Trial Document Cover Page 
Official Title: 
Impact of TruNatomy and ProTaper Gold Ni-Ti Systems Using Resin-Based or Bioceramic 
Sealers on Postoperative Pain After Root Canal Treatment: A Randomized Clinical Trial  
Acronym: 
POP 
NCT Number: 
NCT07526844 
Document Type: 
Study Protocol and Consent Form 
Date: 
April 15, 2026 
Institution: 
Faculty of Dentistry 
European University of Lefke 
 
Asst. Prof. Dr. Mohamad Abduljalil 
https://orcid.org/0000-0002-2244-9285 
 
 
 
 
 
 
 
 
 
 
 

Impact of Trunatomy and Protaper Gold Ni-Ti Systems Using Resin-Based or Bioceramic 
Sealers on Postoperative Pain After Root Canal Treatment: A Randomized Clinical Trial 
Introduction 
Postoperative pain following root canal treatment is a critical factor influencing both clinical success 
and patient comfort. Despite advances in endodontic techniques, pain after treatment remains a common 
concern and may negatively affect patient perception of care (1, 2). 
Postoperative pain is multifactorial in origin and may result from microbial, chemical, and mechanical 
factors. Microbial causes include residual infection due to inadequate chemo-mechanical preparation 
or coronal leakage. Chemical factors involve the use of irrigants, intracanal medicaments, and 
obturation materials. Mechanical factors include apical extrusion of debris, irrigants, and 
microorganisms, as well as trauma to periapical tissues during instrumentation (1, 2). 
Among these factors, the root canal preparation technique plays a crucial role in the development of 
postoperative pain. TruNatomy (Dentsply Maillefer, Ballaigues, Switzerland) is a recently introduced 
rotary system designed for minimally invasive canal shaping. Its slim design and regressive taper allow 
preservation of dentin and natural canal anatomy, which may reduce apical extrusion of debris and 
postoperative discomfort (1). 
In contrast, ProTaper Gold (Dentsply Maillefer, Ballaigues, Switzerland) is a widely used rotary system 
characterized by a progressive taper and enhanced cutting efficiency. While effective in shaping 
complex canal anatomies, its more aggressive design may result in increased debris extrusion, 
potentially contributing to postoperative pain (3). 
The type of root canal sealer is another important factor influencing treatment outcomes. Sealer 
extrusion into periapical tissues may induce inflammatory reactions depending on its chemical 
composition. The chemical composition of sealers also influences the degree of tissue response (4, 5). 
AH Plus (Dentsply DeTrey, Konstanz, Germany), an epoxy resin-based sealer, is known for its excellent 
sealing ability and dimensional stability. In contrast, TotalFill BC Sealer (FKG Dentaire SA, La Chaux-
de-Fonds, Switzerland), a calcium silicate–based bioceramic sealer, demonstrates favorable 
biocompatibility and bioactivity through calcium ion release (6). 
The aim of this study is to evaluate the effect of two rotary file systems (TruNatomy and ProTaper 
Gold) used in combination with two different sealers (AH Plus and TotalFill BC) on postoperative pain 
in patients with asymptomatic irreversible pulpitis. 
The null hypothesis is that neither the instrumentation system nor the sealer type, nor their interaction, 
has a significant effect on postoperative pain. 
Methods 
This study is designed as a prospective, randomized clinical trial. Ethical approval was obtained from 
the European University of Lefke Ethics Committee (Protocol No: BAYEK057.03). 
Sample Size Calculation 
A total of 180 patients will be recruited and randomly allocated into four groups (n = 45 per group). 
Considering an anticipated dropout rate of approximately 20%, the final analyzable sample size is 
expected to be 144 patients (36 per group). 

 
This sample size provides 80% power to detect a moderate effect size (Cohen’s d ≈ 0.42) and 90% 
power to detect a larger effect (d ≈ 0.48) at a significance level of 5%. It also allows evaluation of 
potential interaction effects between the instrumentation system and sealer type. 
Patient Selection 
Patients will be recruited from individuals referred to the European University of Lefke Dental Clinic 
for root canal treatment. Only mandibular first and second premolars diagnosed with asymptomatic 
irreversible pulpitis will be included. This condition is defined as inflamed vital pulp tissue without 
clinical symptoms, caused by caries, caries removal, or trauma (7). 
Written and verbal informed consent will be obtained from all participants prior to treatment (Appendix 
1). An electronic questionnaire including the Numerical Rating Scale (NRS) and analgesic intake will 
be sent to patients (Appendix 2). Patients will be contacted by phone and asked to complete the 
questionnaire online. Submitted responses will not be editable. The primary outcome will be 
postoperative pain, while secondary outcomes will include analgesic consumption and flare-up 
incidence. 
Inclusion Criteria 
 
Asymptomatic teeth with delayed positive response to thermal and electric pulp testing 
 
Vital teeth with signs of irreversible pulpitis 
 
Mature mandibular first or second premolars 
 
Periodontally healthy teeth 
Exclusion Criteria 
 
Patients with systemic conditions (e.g., diabetes, immunocompromised status, pregnancy) 
 
Antibiotic use within the past month 
 
Use of analgesics within 7 days prior to treatment 
 
Known allergy to materials used 
 
Teeth with periapical lesions 
 
Non-vital or symptomatic teeth 
 
Teeth requiring post-core restorations 
 
Calcified canals, root resorption, or immature teeth 
Randomization and Blinding 
Participants will be randomly assigned to one of four groups using a computer-generated randomization 
sequence. Allocation concealment will be ensured using sealed opaque envelopes. 
Patients and outcome assessors will be blinded to group allocation. Due to the nature of the intervention, 
the operator could not be blinded. 
A total of 180 sealed envelopes containing combinations of TruNatomy or ProTaper Gold systems and 
AH Plus or TotalFill BC sealers will be prepared and mixed in an opaque container. Each patient will 
select one envelope, which determines the assigned group. To minimize bias, the operator will open the 
envelope only after gaining access to the root canal. 
 

Treatment Protocol 
All procedures will be performed by a single experienced clinician in a standardized clinical setting, 
using the same irrigation solutions and obturation techniques, and completed in a single visit. 
Inferior alveolar nerve block anesthesia will be administered using 2% articaine hydrochloride with 
1:80,000 epinephrine (Jetokain; Adeka). After rubber dam isolation, caries and old restorations will be 
removed, and standard access cavities will be prepared. 
Working length will be determined using an electronic apex locator (Raypex 6; VDW) and confirmed 
radiographically. Glide path preparation will be performed using size 8–10 K-files, and apical patency 
will be confirmed with a size 10 K-file. 
Root Canal Shaping 
 
TruNatomy Groups (Groups 1–2): 
Preparation will be performed at 500 rpm and 1.5 Ncm torque using TruNatomy Glider 
(17/0.02) followed by Prime file (26/0.04). 
 
ProTaper Gold Groups (Groups 3–4): 
Preparation will be performed at 300 rpm and 2 Ncm torque using ProGlider followed by SX, 
S1, S2, F1, and F2 files. 
Irrigation with 2.5% NaOCl will be performed using a 30-gauge side-vented needle. Final irrigation 
will include activated NaOCl (EndoActivator), EDTA, distilled water, and 2% chlorhexidine. 
Obturation 
Modified single-cone technique will be used: 
 
Group 1: TruNatomy + AH Plus  
 
Group 2: TruNatomy + TotalFill BC  
 
Group 3: ProTaper Gold + AH Plus  
 
Group 4: ProTaper Gold + TotalFill BC  
Excess gutta-percha will be removed and compacted below CEJ, followed by composite restoration 
(Filtek Z250; 3M ESPE). 
Postoperative Pain Assessment 
Primary Outcome 
Postoperative pain will be evaluated at different time points—6, 12, 24, 48, and 72 hours, as well as on 
the 7th day—using the Numerical Rating Scale (NRS). The NRS is a numerical version of the Visual 
Analog Scale (VAS), ranging from 0 (no pain) to 10 (unbearable pain) (8, 9). It will be explained to 
participants as follows: 
 
No pain (0) 
 
Mild pain (1–3): Low-level pain that does not require analgesics 
 
Moderate pain (4–6): Tolerable pain that can be controlled with analgesics\ 
 
Severe pain (7–10): Unbearable pain that is not adequately controlled by analgesics and often 
requires rest 
Postoperative Analgesic Protocol: All patients will be prescribed 400 mg ibuprofen and will be 
advised to use it only in cases of severe pain. Analgesic intake will be recorded. 

Follow-up Visits: Follow-up visits will be scheduled on the 7th day to clinically confirm patient-
reported outcomes. 
Statistical Analysis 
Data will be analyzed using appropriate statistical software. Statistical significance will be set at p < 
0.05. 
References 
1. Vardar Korkman Ç, Haznedaroğlu F. Comparison of postoperative pain after 
instrumentation with TruNatomy or ProTaper Next Ni-Ti systems in mandibular molars with 
asymptomatic apical periodontitis: a randomized clinical trial. BMC Oral Health. 
2025;25(1):564. Published 2025 Apr 13. doi:10.1186/s12903-025-05895-6 
2. Aslan T, Dönmez Özkan H. The effect of two calcium silicate-based and one epoxy resin-
based root canal sealer on postoperative pain: a randomized controlled trial. Int Endod J. 
2021;54(2):190-197. doi:10.1111/iej.13411 
3. Kim DH, Choi YW, Kang S, Shin SJ, Jung IY. Postoperative pain of minimally invasive 
root canal treatment:a randomized clinical trial. Odontology. 2024;112(4):1307-1315. 
doi:10.1007/s10266-024-00912-6. 
4. Froes FG, Miranda AM, Abad Eda C, Riche FN, Pires FR. Non-surgical management of 
paraesthesia and pain associated with endodontic sealer extrusion into the mandibular canal. 
Aust Endod J. 2009;35(3):183-186. doi:10.1111/j.1747-4477.2009.00163.x. 
5. Zhang W, Peng B. Tissue reactions after subcutaneous and intraosseous implantation of 
iRoot SP, MTA and AH Plus. Dent Mater J. 2015;34(6):774-780. doi:10.4012/dmj.2014-271. 
6. López-García, S., Pecci-Lloret, M. R., Guerrero-Gironés, J., Pecci-Lloret, M. P., Lozano, A., Llena, 
C., Rodríguez-Lozano, F. J., & Forner, L. (2019). Comparative Cytocompatibility and Mineralization 
Potential of Bio-C Sealer and TotalFill BC Sealer. Materials (Basel, Switzerland), 12(19), 3087. 
7. American Association of Endodontists. (2020) Glossary of endodontic terms, 10th edition. 
Chicago: American Association of Endodontists. 
8. Çanakçi BC, Er Ö, Genç Şen Ö, Süt N. The effect of two rotary and two reciprocating NiTi systems 
on postoperative pain after root Canal retreatment on single-rooted incisor teeth: A randomized 
controlled trial. Int Endod J. 2021;54(11):2016–24. 
9. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six 
methods. Pain. 1986;27(1):117–26.  
 
 
 

Appendix 1. Patient Informed Consent Form 
Study Title: Impact of Trunatomy and Protaper Gold Ni-Ti Systems Using Resin-Based or 
Bioceramic Sealers on Postoperative Pain After Root Canal Treatment: A Randomized 
Clinical Trial 
Principal Investigator: Dt. Kaan Nurhan 
Faculty of Dentistry, European University of Lefke 
 
1. Purpose of the Study 
You are invited to participate in a research study. The aim is to compare two different systems 
for cleaning root canals and two different root canal sealers used to fill the canals after cleaning. 
All systems and sealers are commonly used in dental practice and considered safe. We want to 
see if there is any difference in the level of pain patients feel after treatment depending on the 
file system and sealer used. 
2. Procedures 
 
If you agree, root canal treatment will be performed on the tooth that has been 
indicated as irreversible pulpitis, and during this procedure, one of the file systems 
and one of the sealers included in the study will be used. 
 
You will be randomly assigned to one of the study groups (instrument system + 
sealer). 
 
The treatment will follow standard clinical procedures: local anesthesia, cleaning and 
shaping of the root canals, irrigation, and obturation (filling) using one of the two 
tested sealers. 
 
After treatment, you will be asked to record your level of pain on a 0–10 scale at 
several times (6h, 12h, 24h, 48h, 72h and 7 days). 
 
You may also receive a follow-up phone call to confirm your pain scores. 
 
You will be given pain-relief medication to use if needed and asked to record your 
use. 
3. Risks and Discomforts 
 
Root canal treatment may cause temporary discomfort or pain after the procedure. 
 
There are no additional risks from participating in this study compared with routine 
root canal treatment. 
 
All file systems and sealers used are approved and commonly applied in dental 
practice. 
 
If you feel severe pain or swelling, you can contact your dentist immediately. 
4. Benefits 
 
You will receive necessary root canal treatment for your tooth. 
 
The information collected may help improve treatment protocols and patient comfort 
in the future. 
 

5. Voluntary Participation 
 
Your participation is voluntary. You may refuse to join or withdraw at any time 
without affecting your dental treatment. 
 
If you decide not to participate, you will still receive appropriate treatment. 
6. Confidentiality 
 
Your personal data will be kept strictly confidential. 
 
Only coded study numbers will be used in the research data. 
 
Results may be published in scientific journals, but your identity will never be 
revealed. 
7. Costs and Compensation 
 
You will not have to pay any additional costs for participation. 
 
You will not receive financial compensation for participation. 
8. Questions 
If you have any questions about the study, you may contact: 
Dt. Kaan Nurhan,  
Faculty of Dentistry European University of Lefke 
Phone Number: 00905338406054 
Email: knurhan@eul.edu.tr 
9. Consent Statement 
I have read and understood the information provided above. I have had the opportunity to ask 
questions and they have been answered to my satisfaction. I voluntarily agree to participate in 
this study. 
Participant’s Name: ______________________________ 
 
Signature of Participant: _________________________ Date: __________ 
 
Researcher’s Name: _______________ 
 
Signature of Researcher: _________________________ Date: __________ 
 
 
 

Appendix 2. Patient Pain Diary Form 
Study Title: Impact of Trunatomy and Protaper Gold Ni-Ti Systems Using Resin-Based or Bioceramic Sealers on 
Postoperative Pain After Root Canal Treatment: A Randomized Clinical Trial 
Participant ID: ______________________ 
Date of Treatment: __________________ 
Tooth Number: ______________________ 
Instructions to the Patient 
After your root canal treatment, please record the level of pain you experience at the following time intervals. Use the 
Numerical Rating Scale (NRS) below to indicate the intensity of your pain: 
Pain Score 
Description 
0 
No pain 
1–3 
Mild pain 
4–6 
Moderate pain 
7–10 
Severe pain 
 
Numerical Rating Scale (NRS): 0  1  2  3  4  5  6  7  8  9  10 
(0 = No Pain   10 = Worst Possible Pain) 
Pain Record Table 
Time After 
Treatment 
Date / Time Recorded 
Pain 
Score 
(0–10) 
Notes (e.g., pain type, analgesic taken, other symptoms) 
6 hours 
 
 
 
12 hours 
 
 
 
24 hours 
 
 
 
48 hours 
 
 
 
72 hours 
 
 
 
7th day 
 
 
 
Analgesic Use (if any): 
Medication Name 
Dose 
Time Taken 
Reason (if other than pain) 
 
 
 
 
 
 
 
 
 
 
Patient Signature: ________________________        Date: ________________________ 
Investigator Signature: ________________________        Date: ________________________