Measuring Apical Debris Extrusion With a Novel Laboratory Technique

NCT07341451 | Completed

• 2 other identifiers: 2025/53923068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Endodontic treatment occupies a critical role in dentistry, serving to prolong the longevity of teeth within the oral cavity and prevent early tooth loss. This treatment is particularly indicated in cases where the pulp tissue is infected or has suffered damage. The primary objective of endodontic treatment is to clean the infected pulp tissue, shape the root canals, and adequately fill these spaces to preserve the functionality of the tooth. A successful endodontic procedure is essential not only for ensuring the longevity of the tooth but also for delaying resorption in surrounding tissues. Furthermore, it allows the patient to maintain masticatory function without losing proprioceptive sensation, which is a key indicator of the treatment's success. During root canal instrumentation, there is a risk of necrotic debris, microorganisms, and dentin particles being displaced through the apical foramen into the periapical tissue. This displacement can increase the risk of infection and lead to postoperative complications. The preservation of the apical foramen is one of the most critical stages in the endodontic treatment process. Materials that extrude beyond the apical foramen can cause irritation and inflammation in the alveolar bone. This situation may exacerbate postoperative pain and discomfort, negatively affecting the patient's satisfaction with the treatment. Additionally, such displacements can compromise the overall success of the procedure by increasing the risk of reinfection. Therefore, preventing these displacements during root canal shaping is a factor that directly influences the success of the treatment. In the literature, precision scales are commonly used to measure the materials displaced from the apex. However, there are discrepancies regarding the reliability of these scales, particularly concerning their measurement accuracy for very small quantities. It has been observed that these precision scales may not provide sufficient accuracy in certain situations, making it challenging to accurately determine the amount of extruded materials. This issue poses a significant barrier to the assessment of endodontic treatment outcomes. Consequently, there is a need for the development of existing measurement methods and the exploration of alternative approaches. The integration of new technologies for measuring the quantity of extruded materials could enhance the understanding and management of treatment processes. In this context, the primary aim of this research is to develop new methods for the more accurate and reliable measurement of materials displaced from the apex. Novel measurement techniques will allow for a more precise determination of the quantity of extruded materials, thereby enhancing the efficacy of endodontic treatment processes. Furthermore, this research aims to contribute to the reduction of postoperative complications and improve patient satisfaction during the treatment process. Ultimately, innovative approaches of this nature are of great importance for the success of endodontic treatments and patient satisfaction. Research in the field of endodontics will not only guide clinical practices but also make significant contributions to the scientific literature. Such innovations will assist in the development of future treatment protocols and the enhancement of patient care.

Conditions

Apical Extrusion During Root Canal Treatment

Keywords

Debris extrusion; Irrigant extrusion; ProTaper Next; ProTaper Gold; Apical extrusion; Chromium-cobalt particles; Metal particles; Barium sulfate; Radiopacity

Outcome Measures

Primary Outcomes (2)

• Radiographic Area of Apically Extruded Debris

  During the single experimental session of root canal instrumentation and irrigation

  Baseline

• Radiographic Area of Apically Extruded Irrigant

  Quantification of apically extruded irrigant using barium sulfate-enhanced NaOCl/EDTA solutions. After instrumentation, standardized digital radiographs are analyzed in ImageJ to measure the radiopaque area and spread pattern of the extruded irrigant on the sponge background.

  Baseline

Study Arms (4)

ProTaper Gold - Debris Extrusion

EXPERIMENTAL

Extracted mandibular premolars shaped with ProTaper Gold rotary files. Apical extrusion of debris measured using chromium-cobalt particles.

Device: ProTaper Gold Rotary File System

ProTaper Next - Debris Extrusion

EXPERIMENTAL

Extracted mandibular premolars shaped with ProTaper Next rotary files. Apical extrusion of debris measured using chromium-cobalt particles.

Device: ProTaper Next Rotary File System

ProTaper Gold - Irrigant Extrusion

EXPERIMENTAL

Extracted mandibular premolars shaped with ProTaper Gold rotary files. Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl.

Device: ProTaper Gold Rotary File System

ProTaper Next - Irrigant Extrusion

EXPERIMENTAL

Extracted mandibular premolars shaped with ProTaper Next rotary files. Apical extrusion of irrigant measured using barium sulfate-enhanced NaOCl

Device: ProTaper Next Rotary File System

Interventions

ProTaper Gold Rotary File System DEVICE

Root canal instrumentation performed using ProTaper Gold rotary file system at working length. Files were used in sequence (S1, F1-F3) following the manufacturer's instructions for torque and rpm. Irrigation was performed with NaOCl during shaping

ProTaper Gold - Debris Extrusion; ProTaper Gold - Irrigant Extrusion

ProTaper Next Rotary File System DEVICE

Root canal instrumentation performed using ProTaper Next rotary file system at working length. Files were used in sequence (X1-X3) following the manufacturer's instructions for torque and rpm. Irrigation was performed with NaOCl during shaping

ProTaper Next - Debris Extrusion; ProTaper Next - Irrigant Extrusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Extracted human mandibular premolars with fully formed apices Single straight root canal confirmed radiographically No resorption, fracture, or previous endodontic treatment No caries or restorations extending into the root canal

You may not qualify if:

• Teeth with multiple canals, severe curvature (\>20°) Immature apices or open apex External or internal root resorption Presence of root fractures, cracks, or structural anomalies Teeth with previous endodontic instrumentation or obturation Teeth with extensive coronal defects that compromise standardization

Sponsors & Collaborators

• necmettin erbakan university Scientific Research Projects (BAP): collaborator
• Fatma Selenay Ucas Yildiz: lead

Study Sites (1)

Necmettin Erbakan University Faculty of Dentistry

Konya, Turkey (Türkiye)

Location

Related Links

• Related Info

Study Officials

• Arslan Terlemez, DDS, PhD

  Necmettin Erbakan University, Faculty of Dentistry, Department of Endodontics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: During root canal instrumentation, the operator could not observe the amount of extruded debris or irrigant. Radiographic evaluation of extrusion was performed afterwards. Although the assessor was aware of group allocation, the extrusion itself was not visible during instrumentation, thus minimizing bias.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant and Principal Investigator

Model Details: Eighty extracted human mandibular premolars were randomly assigned into four parallel groups (n=20 each) to evaluate apical extrusion of debris and irrigants using two different rotary systems (ProTaper Gold, ProTaper Next) and two evaluation methods (metal particles for debris, barium sulfate solution for irrigants)

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: January 14, 2026
• Study Start: September 29, 2025
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)