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The goal of this clinical trial is to compare the pain experienced by healthy participants after root canal treatment with small versus large root canal sizes.
The main questions it aims to answer are:
The researcher will perform root canal treatment on lower molar teeth. The researcher will ask about the pain level, painkiller pill number, and swelling on the 6th,12th, 24th, 48th, 72nd hours, and 7th day after the treatment.
Root canal shaping is an essential step for root canal treatment. Necrotic tissues, debris, microorganisms, and organic matter should be removed to clean and disinfect the root canals. Previously, this conventional procedure involved removing excessive dentine from root canals, which weakened the tooth's structural integrity. Due to technological advances, excessive dentine removal is not always necessary. Root canals are claimed to be disinfected despite minimal dentine removal. This concept of treatment is called minimally invasive or conservative root canal treatment.
This study compares postoperative pain after conservative and conventional root canal preparation in healthy participants with necrotic mandibular molars.
Participants will be enrolled after clinical and radiographic examination by an independent endodontist and allocated randomly to conventional or conservative root canal treatment groups. After the root canal treatment, the researcher will send the participants an online questionnaire on the 6th,12th, 24th, 48th, and 72nd hours and 7th day and ask them to rate their pain score according to the Numerical Rating System and the number of painkillers they have taken. The flare-up rate will be determined according to the presence of swelling and severe pain.
An experienced endodontist not involved in the research will monitor eligible participants and clinical treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: ProTaper Next Nickel-Titanium File (PTN) | Experimental | Root canals will be prepared using the ProTaper Next (PTN) instrument. Coronal flaring will be performed using ProTaper Next XA (accessory) in 300 rpm speed and 2 Ncm torque settings. (The same speed and torque settings will be used for all PTN instruments). The glide path will be prepared with ProGlider (Dentsply, Maillefer). ProTaper Next X1 (17 .04) and then X2 (25 .06) will be advanced in the apical direction using a brushing motion. If debris is observed in the apical part of X2 removed from the root canal after reaching the working length, the shaping of the root canal will be completed, and X3 (30 .07) will not be used. If no debris is observed in the apical part of X2 and the #25 K-File reaches the working length loosely, shaping will be continued with X3. Shaping with ProTaper Next X3 will be done in the same way as X1 and X2. |
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| Group 2: TruNatomy Nickel-Titanium File (TN) | Experimental | Root canals will be prepared using the TruNatomy (TN) instrument. Coronal flaring will be performed using the Orifice Modifier (20 .08) at a speed of 400 rpm and a torque setting of 1.5 Ncm. (The same speed and torque settings will be used for all TN instruments.) The Orifice Modifier will be advanced up to 3 mm within the root canal. The guide path will be prepared with TruNatomy Glider (17 .02-variable taper). The TruNatomy Prime (26 .04) file will be used in the canal by moving it apically back and forth 2-3 times and not exceeding 2-5 mm, using a brushing motion. Before proceeding to the TruNatomy Medium (35 .04) file, the debris accumulated in the apical part of the Prime file will be checked. If there is no debris between the apical flutes of the TruNatomy Prime file, shaping will be continued with the TruNatomy Medium file. Shaping with TruNatomy Medium will be done in the same manner as with TN Prime. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN) | Procedure | ProTaper Next (Dentsply Sirona) is a rotational system made of a nickel-titanium alloy called M-Wire. It has a rectangular cross-sectional design; thus, only two sides touch the root canal. Five files are available: X1 17/. 04, X2 25/.06, X3 30/. 07, X4 40/.06, and X5 50/.06. This file aggressively removes the coronal dentine of root canals due to its large taper. PTN nickel-titanium systemis used in root canal treatments to debride and shape the root canals. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Pain after root canal treatment will be assessed via the Numerical Rating System (NRS) at the 6th, 12th, 24th, 48th, and 72nd hours and on the 7th day. In the NRS, pain is evaluated by numbers from 0 to 10. A score of minimum means no pain, and a score of maximum 10 means the worst pain imaginable. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic intake | Number of painkiller pills will be asked at 6th, 12th, 24th, 48th and 72nd hours and 7th day. | 7 days |
| Flare-up | Presence of Flare-ups will be determined according to swelling and severe pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Faruk HaznedaroÄŸlu | Istanbul University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Faculty of Dentistry | Istanbul | Fatih | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40223067 | Derived | Vardar Korkman C, Haznedaroglu 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 Apr 13;25(1):564. doi: 10.1186/s12903-025-05895-6. |
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| Root Canal Treatment withTruNatomy Nickel-Titanium File (TN) | Procedure | TruNatomy (Dentsply Sirona) is a heat-treated nickel-titanium system that consists of an orifice modifier, glide path, and shaping files. The TruNatomy Small, Prime, and Medium files have sizes of 20/.04, 26/.04, and 35/.04, respectively. It has a rectangular cross-section and a regressive taper. Its slim design allows for a conservative preparation of root canals and the preservation of the coronal dentine. TN nickel-titanium system is used in root canal treatments to debride and shape the root canals. |
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| 7 days. |
| ID | Term |
|---|---|
| D010483 | Periapical Diseases |
| D010485 | Periapical Periodontitis |
| D010149 | Pain, Postoperative |
| D003790 | Dental Pulp Necrosis |
| D000067251 | Symptom Flare Up |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007571 | Jaw Diseases |
| D009057 | Stomatognathic Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D010518 | Periodontitis |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009336 | Necrosis |
| D012008 | Recurrence |
| D020969 | Disease Attributes |
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