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Root Canal TreatmentNCT07699432

Different Kinematics Within a Single-File System and Postoperative Pain

A study testing Twisted Adaptive motion (TFA), canal pro jeni and forward reciprocation in people with Root Canal Treatment and Postoperative Pain, run by Jordan University of Science and Technology at 1 site in Jordan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this clinical trial is to evaluating the influence of single file rotary system for root canal instrumentation using different kinematics on postoperative pain, the primary purpose: measuring post-operative pain by Numerical rating scale in a cohort population treatyed in Jordan Universoit of science and… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Twisted Adaptive motion (TFA), canal pro jeni and forward reciprocation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteJordan
Study dates
10 Apr 2024to 10 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients aged between 18-65 year
  • Fully mature roots
  • Asymptomatic
  • Not taking neither antibiotics nor analgesics withing last 2 weeks
  • ASA I and ASA II

Who cannot join

  • patients that are younger or older than the selected age group 18-65 years - Immature roots
  • Symptomatic, presence of sinus tract, fistula, or swelling.
  • patient on medication antibiotics or analgesics withing last 2 weeks -Pregnant women,
  • retreatment cases,
  • allergic reactions
  • resorption in the relevant tooth,
Show all 10Show fewer
  • periapical abscess,
  • apical resorption, systemic diseases,ASA III-VI
  • inability to understand the treatment procedure
  • Any mesial canals with initial apical file larger than ISO 20

Trial locations and contacts

1 site in 1 country.

Jordan1 site
  • Jordan University of science and technology

    Irbid, Northen, 22110

Other trials in Jordan

About this study

Official title: The Impact of Employing Different Kinematics Within a Single-File System on the Perception of Postoperative Pain: A Randomized Clinical Trial

The goal of this clinical trial is to evaluating the influence of single file rotary system for root canal instrumentation using different kinematics on postoperative pain, the primary purpose: measuring post-operative pain by Numerical rating scale in a cohort population treatyed in Jordan Universoit of science and technology post graduate clinics with previously intittaed root canal treatement and could include any of the following: sex/gender, age groups (18-65 ), and healthy volunteers.

The main questions it aims to answer [is/are:

  • Is there any difference in postoperative pain after root canal treatment with different kinamtics
  • Is this correlated with the level of cytokines measured taken from inside the canal system before and after treament whioch will be analyzed by the ELISA Kit for pain biomarkers.
  • Is this related to in vitro debris extrusion, and can it validate previous research with the same methodology for debris extrusion measurement Researchers will compare 5 groups, which are Canal pro jeni, Continuous clockwise rotation (CCR), Optimum Torque Reverse (OTR), Forward reciprocating motion (REC), and Twisted Adaptive motion (TFA). All motions will be used with the One Curve file system Participants will report the level of pain after traatment level of cytokines will be measured by taking samples from the periapical area before, during, and after trematemtn
Read the detailed description

This prospective, randomized, parallel-group clinical trial will evaluate whether the kinematics used during root canal instrumentation with a single-file system influence postoperative pain and the local expression of pain-related neuropeptides. The trial will be conducted in adult patients requiring endodontic treatment of mandibular molars. Eligible participants will be enrolled after clinical and radiographic assessment and after obtaining written informed consent.

Participants will be randomly allocated to one of five treatment groups. In all groups, canal shaping will be performed using the same One Curve nickel-titanium single-file system, while the kinematic motion used to activate the file will differ between groups. The tested kinematics will include CanalPro Jeni motion, continuous clockwise rotation, optimum torque reverse motion, forward reciprocating motion, and twisted adaptive motion. This design allows the effect of instrument motion to be assessed while maintaining the same file system across all study arms.

All treatments will be performed under standardized clinical conditions. Local anesthesia will be administered and the tooth will be isolated with a rubber dam. Access cavity preparation, canal identification, manual scouting, working length determination, and radiographic confirmation will be completed using a standardized approach. Initial irrigation will be performed before instrumentation, and the allocated kinematic protocol will then be used for canal preparation according to the study protocol.

Periapical fluid samples will be collected using sterile paper points at predefined procedural time points. The sampling schedule will include collection during the initial stage of canal preparation, after instrumentation, and at the follow-up visit. Samples will be transferred to sterile tubes and stored under appropriate laboratory conditions until analysis. The collected samples will be analyzed using enzyme-linked immunosorbent assay methods to quantify selected neuropeptides associated with inflammatory pain response, including substance P and calcitonin gene-related peptide.

The clinical treatment will be completed over two visits. At the first visit, the canals will be prepared using the allocated kinematic protocol and irrigated using a standardized irrigation sequence. Intracanal medicament will be placed between visits, and the tooth will be temporized. At the second visit, patient-reported pain and percussion sensitivity will be recorded, the temporary restoration and intracanal medicament will be removed, and periapical fluid will be collected before completion of the final irrigation protocol. The canals will then be dried, obturated using gutta-percha and resin-based sealer, and restored with an adhesive restorative material. A postoperative radiograph will be taken as part of routine treatment documentation.

Postoperative pain will be recorded by the participant at scheduled time points after treatment using a standardized pain scale. Clinical follow-up information and laboratory biomarker data will be collected using structured forms. The trial procedures will be performed by trained clinicians, and laboratory analysis will be performed according to the manufacturers' instructions for the selected assay kits. Data handling and storage will follow institutional requirements for clinical research.

The analysis will compare postoperative pain scores and biomarker levels between the five kinematic groups. Descriptive statistics will be used to summarize participant characteristics, pain scores, and biomarker concentrations. Appropriate statistical tests will be selected according to the type and distribution of the data. The analysis will assess whether differences in file kinematics are associated with differences in patient-reported postoperative pain and changes in pain-related neuropeptide levels.

Being tested
Twisted Adaptive motion (TFA), canal pro jeni, forward reciprocation, continuous rotation, Optimum Torque Reverse (OTR)
Keywords
Optimum Torque Reverse (OTR),, forward reciprocation, continuous rotation, postoperative pain, TF adaptive (TFA), CanalPro Jeni, substance P, calcitonin gene related peptide (CGRP)
Medical subject headings
Pain, Postoperative, Periapical Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Twisted Adaptive motion (TFA)Device

    motor that is capable of doing the adaptive motion

  • canal pro jeniDevice

    a new kinematics for root canal treatment

  • forward reciprocationDevice

    endodontic motor with the ability to change reciprocating angles and speed

  • continuous rotationDevice

    endodontic dental motor

  • Optimum Torque Reverse (OTR)Device

    endodontic motor that is designed for rotate in Optimum Torque Reverse (OTR)

Study groups in NCT07699432
Study groupRoleWhat they receive
canal pro JeniActive comparatormotion kinematics by canal pro Jeni
Receives: Device: canal pro jeni
Optimum Torque Reverse (OTR)Active comparatorMotion kinematics by Optimum Torque Reverse (OTR)
Receives: Device: Optimum Torque Reverse (OTR)
Continuous clockwise rotation (CCR)Active comparatorMotion kinematics by Continuous clockwise rotation (CCR)
Receives: Device: continuous rotation
Forward reciprocating motion (REC)Active comparatorMotion kinematics by Forward reciprocating motion (REC)
Receives: Device: forward reciprocation
Twisted Adaptive motion (TFA)Active comparatorMotion kinematics by Twisted Adaptive motion (TFA)
Receives: Device: Twisted Adaptive motion (TFA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain

    Pain will be assessed using the Visual Analogue Scale (VAS). The VAS is a self-reported instrument with scores ranging from a minimum of 0 (no pain) to a maximum of 10 (worst possible pain). Higher scores indicate a worse clinical outcome (more severe pain).

    Measured: Up to 48 hours post-treatment

Secondary outcomes (1)
  1. Change in Cytokine Levels

    Measurement of cytokine levels in (pg/mL) to evaluate the inflammatory response. Samples are collected immediately before treatment, immediately following treatment on Day 1, and on Day 3 prior to obturation

    Measured: From baseline up to Day 3 post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start10 Apr 2024
  3. Primary completion10 May 2026
  4. Study completion10 Sep 2026 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07699432
Sponsor's protocol ID
20240405
Other IDs
20240405
Status last verified
Jul 2026
First submitted
24 Feb 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: At the publication stage, the IPD will be shared

Publications

  • 24. https://whyy.org/segments/reassessing-the-assessment-of-pain-how-the-numeric-scale-became-so-popular-in-health-care

  • Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.

    PubMed 29398090
  • Al Omari TMN, La Rosa GRM, Albanna RHI, Tabnjh A, Papale F, Pedulla E. The effect of different kinematics on apical debris extrusion with a single-file system. Odontology. 2023 Oct;111(4):910-915. doi: 10.1007/s10266-023-00802-3. Epub 2023 Mar 14.

    PubMed 36917401
  • Pirani C, Iacono F, Zamparini F, Generali L, Prati C. Retreatment of Experimental Carrier-Based Obturators with the Remover NiTi Instrument: Evaluation of Apical Extrusion and Effects of New Kinematics. Int J Dent. 2021 Oct 23;2021:2755680. doi: 10.1155/2021/2755680. eCollection 2021.

    PubMed 34725547
  • 19. J Morita Corporation (2016) DentaPort ZX Set OTR brochure. Available at: http://www.jmoritaeurope.de/cms/file s/MO_65827_Update_B_Dentaport_RZ_en.pdf. [Accessed on 3 September 2016]

  • Gambarini G, Piasecki L, Miccoli G, Gaimari G, Di Giorgio R, Di Nardo D, Azim AA, Testarelli L. Classification and cyclic fatigue evaluation of new kinematics for endodontic instruments. Aust Endod J. 2019 Aug;45(2):154-162. doi: 10.1111/aej.12294. Epub 2018 Aug 16.

    PubMed 30113735
  • Capar ID, Ertas H, Ok E, Arslan H, Ertas ET. Comparative study of different novel nickel-titanium rotary systems for root canal preparation in severely curved root canals. J Endod. 2014 Jun;40(6):852-6. doi: 10.1016/j.joen.2013.10.010. Epub 2013 Nov 7.

    PubMed 24862716
  • 16. https://www.kerrdental.com/ca/kerr-endodontics/elements-motor-adaptive-motion-shape#docs

  • AlOmari T, AlThobiti G, AlThobaiti S, AlOufi F, Masuadi E, Jamleh A. Incidence of postoperative pain after canal shaping by using Reciproc and Twisted File Adaptive systems: a prospective, randomized clinical trial. Clin Oral Investig. 2020 Jul;24(7):2445-2450. doi: 10.1007/s00784-019-03106-5. Epub 2019 Nov 1.

    PubMed 31673858
  • Gambarini G, Gergi R, Naaman A, Osta N, Al Sudani D. Cyclic fatigue analysis of twisted file rotary NiTi instruments used in reciprocating motion. Int Endod J. 2012 Sep;45(9):802-6. doi: 10.1111/j.1365-2591.2012.02036.x. Epub 2012 Mar 19.

    PubMed 22429241
  • Saricam E, Kayaoglu G. Comparison of OneShape, 2Shape and One Curve endodontic instruments for debris and irrigant extrusion. Dent Med Probl. 2020 Jul-Sep;57(3):255-259. doi: 10.17219/dmp/119771.

    PubMed 33064376
  • Ahn SY, Kim HC, Kim E. Kinematic Effects of Nickel-Titanium Instruments with Reciprocating or Continuous Rotation Motion: A Systematic Review of In Vitro Studies. J Endod. 2016 Jul;42(7):1009-17. doi: 10.1016/j.joen.2016.04.002. Epub 2016 May 13.

    PubMed 27185740
  • Caviedes-Bucheli J, Castellanos F, Vasquez N, Ulate E, Munoz HR. The influence of two reciprocating single-file and two rotary-file systems on the apical extrusion of debris and its biological relationship with symptomatic apical periodontitis. A systematic review and meta-analysis. Int Endod J. 2016 Mar;49(3):255-70. doi: 10.1111/iej.12452. Epub 2015 Apr 22.

    PubMed 25816688
  • Yammine SD, Jabbour EA. Apically Extruded Debris following Programmed Over Instrumentation of Curved Canals with Three Nickel Titanium Rotary Instruments. Eur J Dent. 2021 Feb;15(1):20-26. doi: 10.1055/s-0040-1714175. Epub 2020 Aug 26.

    PubMed 32864731
  • Caviedes-Bucheli J, Munoz HR, Azuero-Holguin MM, Ulate E. Neuropeptides in dental pulp: the silent protagonists. J Endod. 2008 Jul;34(7):773-88. doi: 10.1016/j.joen.2008.03.010.

    PubMed 18570980

Questions about this trial

What is this clinical trial studying?

A study testing Twisted Adaptive motion (TFA), canal pro jeni and forward reciprocation in people with Root Canal Treatment and Postoperative Pain, run by Jordan University of Science and Technology at 1 site in Jordan.

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 10 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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 Jordan. 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?

This study is still under way. Results are not available in the source record yet.

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: Up to 48 hours post-treatment). 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 NCT07699432, which also lists 22 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 13 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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