Periapical DiseasesNCT06545773
Postoperative Pain After Conservative Root Canal Preparation
A study testing Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN) and Root Canal Treatment withTruNatomy Nickel-Titanium File (TN) in people with Periapical Diseases and Periapical Periodontitis, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
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: 1. Do small and large root canal sizes cause different pain levels? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periapical Diseases, Periapical Periodontitis, Postoperative Pain
- What is being tested?
- Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN) and Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2024to 25 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mandibular molar tooth
- asymptomatic apical periodontitis
- pulp necrosis
- periapical lesion index 4 (visible and well-defined periapical lesion)
- absence of pretreatment pain
Who cannot join
- symptomatic apical periodontitis
- preoperative pain
- sinus tract
- pulpitis
- acute apical abscess
- tooth not being in occlusion
Show all 11Show fewer
- external and internal root resorption
- open apices
- periodontal probing depth of more than 4 mm
- initial apical file larger than 15 and 20 K-File for mesial and distal canals respectively
- chronic illness, analgesic allergy, prior analgesic and antibiotics usage 12 hours and 3 months before treatment, respectively
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Faculty of Dentistry
Istanbul, Fatih
About this study
Official title: Effect of Conservative Root Canal Preparation on Postoperative Pain: A Randomised Clinical Trial
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:
- Do small and large root canal sizes cause different pain levels?
- What is the number of painkiller pills taken by each participant?
- Does small root canal size cause severe pain and facial swelling?
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.
Read the detailed description
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.
- Conditions
- Periapical Diseases, Periapical Periodontitis, Postoperative Pain, Pulp Necroses, Flare Up, Symptom
- Being tested
- Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN), Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)
- Keywords
- pain, Nickel Titanium (NiTi), conservative root canal treatment, minimally invasive, flare-up, analgesic
- Medical subject headings
- Periapical Diseases, Periapical Periodontitis, Pain, Postoperative, Dental Pulp Necrosis, Symptom Flare Up, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN)Procedure or surgery
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.
Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN) |
| 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. Receives: Procedure: Root Canal Treatment withTruNatomy Nickel-Titanium File (TN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (2)
Analgesic intake
Number of painkiller pills will be asked at 6th, 12th, 24th, 48th and 72nd hours and 7th day.
Measured: 7 days
Flare-up
Presence of Flare-ups will be determined according to swelling and severe pain.
Measured: 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start4 Mar 2024
- Primary completion18 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagla Vardar, Istanbul University
- Investigators
- Faruk Haznedaroğlu, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545773
- Sponsor's protocol ID
- IstanbulU-1
- Status last verified
- Oct 2024
- First submitted
- 1 Aug 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40223067
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Conservative Root Canal Preparation on Postoperative Pain: A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT06545773
- Acronym / sponsor ID
- IstanbulU-1
- Conditions
- Periapical Diseases, Periapical Periodontitis, Postoperative Pain, Pulp Necroses, Flare Up, Symptom
- Keywords
- pain, Nickel Titanium (NiTi), conservative root canal treatment, minimally invasive, flare-up, analgesic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do small and large root canal sizes cause different pain levels?
- What is the number of painkiller pills taken by each participant?
- Does small root canal size cause severe pain and facial swelling?
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: ProTaper Next Nickel-Titanium File (PTN) | Experimental | Procedure: Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN)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. |
| Group 2: TruNatomy Nickel-Titanium File (TN) | Experimental | Procedure: Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mandibular molar tooth
- asymptomatic apical periodontitis
- pulp necrosis
- periapical lesion index 4 (visible and well-defined periapical lesion)
- absence of pretreatment pain
Key exclusion criteria (11 listed)
- symptomatic apical periodontitis
- preoperative pain
- sinus tract
- pulpitis
- acute apical abscess
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN)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. | Procedure or surgery | Group 1: ProTaper Next Nickel-Titanium File (PTN) |
| Root Canal Treatment withTruNatomy Nickel-Titanium File (TN)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. | Procedure or surgery | Group 2: TruNatomy Nickel-Titanium File (TN) |
Primary outcome
Postoperative pain
Time frame: 7 days
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.
2 secondary outcomes
Analgesic intake
Time frame: 7 days
Flare-up
Time frame: 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 40223067Vardar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Faruk Haznedaroğlu study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root Canal Treatment with ProTaper Next Nickel-Titanium File (PTN) and Root Canal Treatment withTruNatomy Nickel-Titanium File (TN) in people with Periapical Diseases and Periapical Periodontitis, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06545773, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.