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Different Kinematics Within a Single-File System and Postoperative Pain

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07699432
Enrollment
75
Registered
2026-07-13
Start date
2024-04-10
Completion date
2026-09-10
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apical Periodontitis, Postoperative Pain, Root Canal Treatment

Keywords

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

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

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.

Interventions

DEVICETwisted Adaptive motion (TFA)

motor that is capable of doing the adaptive motion

DEVICEcanal pro jeni

a new kinematics for root canal treatment

DEVICEforward reciprocation

endodontic motor with the ability to change reciprocating angles and speed

DEVICEcontinuous rotation

endodontic dental motor

DEVICEOptimum Torque Reverse (OTR)

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

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

biomarker analysis technician

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative PainUp to 48 hours post-treatmentPain 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).

Secondary

MeasureTime frameDescription
Change in Cytokine LevelsFrom baseline up to Day 3 post-treatmentMeasurement 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

Countries

Jordan

Contacts

PRINCIPAL_INVESTIGATORTaher Mohammed Al Omari, BDS, MSc, JB Endo, M Endo RCSE

Jordan University of Science and Technology

STUDY_CHAIRAladdin Al Qudah, BDS, MSc, PhD

Jordan University of Science and Technology

STUDY_CHAIRLina Elsalem Elsalem, BDS, MSc, PhD

Jordan University of Science and Technology

STUDY_CHAIRRami AL Banna, BDS, JB Endo

Jordan University of Science and Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 14, 2026