Different Kinematics Within a Single-File System and Postoperative Pain

NCT07699432 | Active Not Recruiting FDA Device

• 1 other identifier: 20240405
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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

Conditions

Root Canal Treatment; Postoperative Pain; Apical Periodontitis

Keywords

Optimum Torque Reverse (OTR),; forward reciprocation; continuous rotation; postoperative pain; TF adaptive (TFA); CanalPro Jeni; substance P; calcitonin gene related peptide (CGRP)

Outcome Measures

Primary Outcomes (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).

  Up to 48 hours post-treatment

Secondary Outcomes (1)

• Change in Cytokine Levels

  From baseline up to Day 3 post-treatment

Study Arms (5)

canal pro Jeni

ACTIVE COMPARATOR

motion kinematics by canal pro Jeni

Device: canal pro jeni

Optimum Torque Reverse (OTR)

ACTIVE COMPARATOR

Motion kinematics by Optimum Torque Reverse (OTR)

Device: Optimum Torque Reverse (OTR)

Continuous clockwise rotation (CCR)

ACTIVE COMPARATOR

Motion kinematics by Continuous clockwise rotation (CCR)

Device: continuous rotation

Forward reciprocating motion (REC)

ACTIVE COMPARATOR

Motion kinematics by Forward reciprocating motion (REC)

Device: forward reciprocation

Twisted Adaptive motion (TFA)

ACTIVE COMPARATOR

Motion kinematics by Twisted Adaptive motion (TFA)

Device: Twisted Adaptive motion (TFA)

Interventions

Twisted Adaptive motion (TFA) DEVICE

motor that is capable of doing the adaptive motion

Twisted Adaptive motion (TFA)

canal pro jeni DEVICE

a new kinematics for root canal treatment

canal pro Jeni

forward reciprocation DEVICE

endodontic motor with the ability to change reciprocating angles and speed

Forward reciprocating motion (REC)

continuous rotation DEVICE

endodontic dental motor

Continuous clockwise rotation (CCR)

Optimum Torque Reverse (OTR) DEVICE

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

Optimum Torque Reverse (OTR)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

Jordan University of science and technology

Irbid, Northen, 22110, Jordan

Location

Related Publications (22)

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

  BACKGROUND

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  PMID: 29398090 BACKGROUND

• 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.

  PMID: 36917401 BACKGROUND

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  PMID: 34725547 BACKGROUND

• 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]

  BACKGROUND

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  PMID: 30113735 BACKGROUND

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  PMID: 24862716 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 31673858 BACKGROUND

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  PMID: 22429241 BACKGROUND

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  PMID: 33064376 BACKGROUND

• 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.

  PMID: 27185740 BACKGROUND

• 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.

  PMID: 25816688 BACKGROUND

• 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.

  PMID: 32864731 BACKGROUND

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  PMID: 18570980 BACKGROUND

• Caviedes-Bucheli J, Munoz-Alvear HD, Lopez-Moncayo LF, Kacharaju KR, Velasquez-Rivera AC, Carlosama-Recalde LA, Pazmino JC, Gomez-Sosa JF, Diaz-Barrera LE, Munoz HR. Substance P/calcitonin gene-related peptide and their receptors expression in human periodontal ligament after root canal preparation with five different systems. Int Endod J. 2024 May;57(5):576-585. doi: 10.1111/iej.14035. Epub 2024 Jan 31.

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• Relvas JB, Bastos MM, Marques AA, Garrido AD, Sponchiado EC Jr. Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):1987-1993. doi: 10.1007/s00784-015-1692-0. Epub 2015 Dec 19.

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  PMID: 26614017 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Periapical Periodontitis

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Taher Mohammed Al Omari, BDS, MSc, JB Endo, M Endo RCSE

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

• Aladdin Al Qudah, BDS, MSc, PhD

  Jordan University of Science and Technology

  STUDY CHAIR

• Lina Elsalem Elsalem, BDS, MSc, PhD

  Jordan University of Science and Technology

  STUDY CHAIR

• Rami AL Banna, BDS, JB Endo

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: biomarker analysis technician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2026
• First Posted: July 13, 2026
• Study Start: April 10, 2024
• Primary Completion: May 10, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: june 2026 to june 2027

Locations

JO (1)