Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques

NCT07562139 | Completed

• 1 other identifier: H2022/259
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare two root canal obturation techniques for endodontic treatment in patients aged 15 to 56 years with irreversible pulpitis. The main questions it aims to answer are:

• Receive endodontic treatment for teeth diagnosed with irreversible pulpitis.
• Undergo root canal preparation with Reciproc Blue R25.
• Have canals obturated using either continuous wave condensation or the single-cone technique.
• Be evaluated for obturation time, radiographic quality immediately after treatment, postoperative pain at 4, 24, 48, and 72 hours, and clinical-radiographic outcome at 6 months.

Conditions

Irreversible Pulpitis

Keywords

Endodontics; Root Canal Obturation; Gutta-Percha; Pain Measurement; Radiography, Detal

Outcome Measures

Primary Outcomes (1)

• The rate of 6-month treatment success

  clinical/radiographic per European Society of Endodontology criteria

  6 months

Secondary Outcomes (6)

• Obturation time

  from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed)

• Percentage of canals with adequate obturation length (±2 mm from radiographic apex) assessed by periapical radiograph

  Immediately post-obturation, within 5 minutes after the obturation procedure is completed.

• Percentage of canals/tooth with the presence of voids (radiolucency within filling material) assessed by periapical radiograph

  Immediately post-obturation: within 5 minutes after the obturation procedure is completed.

• Percentage of canals/tooth with apical sealer/gutta-percha extrusion (material beyond radiographic apex) assessed by periapical radiograph

  Immediately post-obturation: within 5 minutes after the obturation procedure is completed.

• Percentage of tooth with the presence of gutta-percha filling in accessory/lateral canals assessed by periapical radiograph

  Immediately post-obturation: within 5 minutes after the obturation procedure is completed.

Study Arms (2)

CWC

EXPERIMENTAL

Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill.

Procedure: Continuous Wave Condensation

SC

ACTIVE COMPARATOR

Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess.

Procedure: Single-Cone

Interventions

Continuous Wave Condensation PROCEDURE

Continuous Wave Condensation (CWC) - Specific Protocol: * EQ-V system (Meta Biomed, South Korea) - NOT System B, Touch'n Heat, or generic pluggers * Precise heat activation: 230°C (manufacturer setting for optimal flow) * Cutting tip positioned 4-6 mm short of working length (prevents over-compaction) * Gutta-percha cone tip pre-trimmed 0.5-1 mm (ensures precise apical control) * Two-stage process: apical hand condensation + thermoplastic backfill * Time measured from cone insertion to final radiograph (includes verification)

CWC

Single-Cone PROCEDURE

* Matched master cone to Reciproc Blue R25 preparation (size/exact tug-back) * Heat trimming at/below orifice (minimizes coronal excess vs cold cutting) * NO supplementary cones or lateral compaction (pure single-cone) * Sealer: AH Plus (Dentsply) - not bioceramic or other brands

SC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Teeth diagnosed with irreversible pulpitis
• Indicated for endodontic treatment
• Patients aged 18-60 years

You may not qualify if:

• Periapical/furcation lesions;
• Need for periodontal surgery
• Periodontal pockets ≥ 5 mm
• Adjacent teeth undergoing endodontic treatment
• Severely fractured or non-restorable crowns
• Immature/abnormal roots
• Internal or external resorption
• Calcified/C-shaped canals
• Canal curvature \>70°
• Failures during canal preparation

Sponsors & Collaborators

• Hue University of Medicine and Pharmacy: lead

Study Sites (1)

Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy, Hue University

Huế, Hue, 49000, Vietnam

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: May 1, 2026
• Study Start: June 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: May 1, 2026

Record last verified: 2024-12

Locations

VN (1)