Postoperative PainPhase 4NCT04616469
Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation
A Phase 4 study testing Root canal treatment using TruNaomy rotary files and Root canal treatment using race rotary instruments in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of: Post operative pain: incidence and intensity Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor Time… Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Root canal treatment using TruNaomy rotary files and Root canal treatment using race rotary instruments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Jul 2024
- Phase
- Phase 4
- 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 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.
- Age between 30-60 years old.
- Males \& Females.
- Patients' acceptance for participating in the trial through an informed consent
- Maxillary permanent premolar teeth:
- Diagnosed clinically and radiographically with pulp necrosis
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- With or without periapical radiolucency
- Negative response of pulp tissue to thermal and electric pulp tester
- Possessing two independent roots each having a type I canal
- Patent canals with no internal calcification or resorptive lesions
- Fully formed roots
- Root curvatures less than 30
Who cannot join
- Patient with contributory medical condition
- Badly destructed teeth
- Patients with pre-operative pain
- Patients having significant systemic disorders
- Patients with two or more adjacent teeth requiring root canal therapy
- Patients who had received antibiotics in the last month
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- Teeth presenting with:
- Positive response to thermal or electric pulp tester
- History of trauma or previous endodontic treatment
- Immature or open apices
- Association with acute periapical abscess and swelling or fistulous tract
- Fused roots at any level
- Canals larger than size 15# K-file
- Periodontonal/ endodontic lesions
- Mobility higher than grade I
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
- Severe root curvature (>30)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial
The aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:
- Post operative pain: incidence and intensity
- Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor
- Time needed for the instruments to reach to the full working length
- Conditions
- Postoperative Pain
- Being tested
- Root canal treatment using TruNaomy rotary files, Root canal treatment using race rotary instruments
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatment using TruNaomy rotary filesProcedure or surgery
Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system
Root canal treatment using race rotary instrumentsProcedure or surgery
Race rotary files will be used for the process of cleaning and shaping of the root canal system
| Study group | Role | What they receive |
|---|---|---|
| Root canal treatment using RaCe rotary system | Active comparator | Canal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity Receives: Procedure: Root canal treatment using race rotary instruments |
| Root canal treatment using TruNatomy rotary system | Experimental | Canal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity Receives: Procedure: Root canal treatment using TruNaomy rotary files |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain using visual analogue scale
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Measured: at 24 hours post treatment
Post operative pain using visual analogue scale
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Measured: at 48 hours post treatment
Post operative pain using visual analogue scale
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Measured: at 72 hours post treatment
Post operative pain using visual analogue scale
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Measured: at 1 week post treatment
Secondary outcomes (2)
operative torque generated during instrumentation
real time operative torque exerted on the instrument through out the shaping process and until the instrument reaches the full working length will be measured using a torque measuring motor in real time
Measured: during treatment
time required for the instrument to reach the full working length
time required for the the instrument to reach the full length and complete the shaping process will be calculated using a Realtime torque motoring motor
Measured: during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 May 2023
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Ali El Mosalamy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616469
- Sponsor's protocol ID
- ENDO:3-3-5 (8-10-2020)
- Status last verified
- Apr 2025
- First submitted
- 8 Oct 2020
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gambarini G, Galli M, Seracchiani M, Di Nardo D, Versiani MA, Piasecki L, Testarelli L. In Vivo Evaluation of Operative Torque Generated by Two Nickel-Titanium Rotary Instruments during Root Canal Preparation. Eur J Dent. 2019 Oct;13(4):556-562. doi: 10.1055/s-0039-1698369. Epub 2019 Dec 31.
PubMed 31891973Zand V, Milani AS, Hassani Dehkharghani A, Rahbar M, Tehranchi P. Treatment of Necrotic Teeth Using Two Engine-Driven Systems and Patient's Postoperative Pain: A Double-Blind Clinical Trial. Iran Endod J. 2016 Fall;11(4):267-272. doi: 10.22037/iej.2016.3.
PubMed 27790254Al-Mosalmy TA, El-Far HM, Gomaa MM, Morsy DA. Impact of root canal shaping using TruNatomy on postoperative pain and operative torque generation: a randomized clinical trial. BMC Oral Health. 2025 Jul 19;25(1):1222. doi: 10.1186/s12903-025-06418-z.
PubMed 40684114
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Root Canal Shaping With TruNatomy on Postoperative Pain and Operative Torque Generated During Instrumentation: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04616469
- Acronym / sponsor ID
- ENDO:3-3-5 (8-10-2020)
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 5 Nov 2020 (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 aim of the present study is to compare the effect of canal shaping using TruNatomy and RaCe rotary systems in bi-rooted maxillary premolars in terms of:
- Post operative pain: incidence and intensity
- Real time torque generated during mechanical instrumentation using real time torque motoring endodontic motor
- Time needed for the instruments to reach to the full working length
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Root canal treatment using RaCe rotary system | Active comparator | Procedure: Root canal treatment using race rotary instrumentsCanal shaping using RaCe rotary system powered with endodontic motor with real time torque monitoring capacity |
| Root canal treatment using TruNatomy rotary system | Experimental | Procedure: Root canal treatment using TruNaomy rotary filesCanal shaping using TruNatomy rotary system powered with endodontic motor with real time torque monitoring capacity |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Patients who are free from any physical or mental handicapping condition and no contributory systemic disease.
- Age between 30-60 years old.
- Males \& Females.
- Patients' acceptance for participating in the trial through an informed consent
- Maxillary permanent premolar teeth:
Key exclusion criteria (17 listed)
- Patient with contributory medical condition
- Badly destructed teeth
- Patients with pre-operative pain
- Patients having significant systemic disorders
- Patients with two or more adjacent teeth requiring root canal therapy
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 using TruNaomy rotary filesTrunatomy rotary files will be used for the process of cleaning and shaping of the root canal system | Procedure or surgery | Root canal treatment using TruNatomy rotary system |
| Root canal treatment using race rotary instrumentsRace rotary files will be used for the process of cleaning and shaping of the root canal system | Procedure or surgery | Root canal treatment using RaCe rotary system |
Primary outcome
Post operative pain using visual analogue scale
Time frame: at 24 hours post treatment
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Post operative pain using visual analogue scale
Time frame: at 48 hours post treatment
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Post operative pain using visual analogue scale
Time frame: at 72 hours post treatment
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
Post operative pain using visual analogue scale
Time frame: at 1 week post treatment
pain after treatment would be measured with a VAS scale from 0-10 cm with zero representing the least amount of pain and 10 representing the worst pain possible
2 secondary outcomes
operative torque generated during instrumentation
Time frame: during treatment
time required for the instrument to reach the full working length
Time frame: during treatment
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 17 Apr 2025.
- Background: PubMed 31891973Gambarini G, Galli M, Seracchiani M, Di Nardo D, Versiani MA, Piasecki L, Testarelli L. In Vivo Evaluation of Operative Torque Generated by Two Nickel-Titanium Rotary Instruments during Root Canal Preparation. Eur J Dent. 2019 Oct;13(4):556-562. doi: 10.1055/s-0039-1698369. Epub 2019 Dec 31.
- Background: PubMed 27790254Zand V, Milani AS, Hassani Dehkharghani A, Rahbar M, Tehranchi P. Treatment of Necrotic Teeth Using Two Engine-Driven Systems and Patient's Postoperative Pain: A Double-Blind Clinical Trial. Iran Endod J. 2016 Fall;11(4):267-272. doi: 10.22037/iej.2016.3.
- Derived from this study: PubMed 40684114Al-Mosalmy TA, El-Far HM, Gomaa MM, Morsy DA. Impact of root canal shaping using TruNatomy on postoperative pain and operative torque generation: a randomized clinical trial. BMC Oral Health. 2025 Jul 19;25(1):1222. doi: 10.1186/s12903-025-06418-z.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Root canal treatment using TruNaomy rotary files and Root canal treatment using race rotary instruments in people with Postoperative Pain, run by Cairo University at 1 site in Egypt.
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 12 inclusion and 17 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 17 Apr 2025. 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 Egypt. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post operative pain using visual analogue scale (time frame: at 24 hours post treatment). The study lists 4 primary outcomes in all. 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 NCT04616469, which also lists 3 linked publications.
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 17 Apr 2025.