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

Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques: A Randomized Clinical Trial

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:

1. Does continuous wave condensation differ from the single-cone technique in obturation time?
2. Does continuous wave condensation differ from the single-cone technique in obturation quality, postoperative pain, and 6-month treatment success? Researchers will compare continuous wave condensation with single-cone obturation to see whether one technique provides better sealing quality, shorter treatment time, less postoperative pain, or higher clinical success.

Participants will:

• 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.

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis
• Intervention / Treatment: Procedure: Continuous Wave Condensation; Procedure: Single-Cone

Detailed Description

Background and Rationale: Irreversible pulpitis requires endodontic treatment to eliminate infection, prevent reinfection, and preserve tooth function. Effective three-dimensional obturation of the root canal system (RCS) is critical for long-term success. The single-cone (SC) technique offers procedural simplicity and reduced chair time but may compromise adaptation to complex canal anatomy. Continuous wave condensation (CWC) uses thermoplasticized gutta-percha to improve sealing of lateral canals and isthmuses. Despite widespread clinical use, comparative clinical data on obturation time, radiographic quality, postoperative pain, and short-term outcomes remain limited, particularly in irreversible pulpitis cases without periapical pathology.

Study Design:

This single-center, superiority, parallel-group randomized clinical trial compared CWC and SC obturation techniques in 60 teeth from 54 patients. Randomization occurred at the tooth level (1:1 allocation) using sequentially numbered opaque sealed envelopes. Operators (two calibrated endodontists) were unblinded due to technique differences; radiographic and clinical assessors remained blinded.

Interventions:

All teeth underwent standardized single-visit treatment under local anesthesia:

Root Canal Preparation (both groups): (1) Access cavity preparation, (2) Working length determination (apex locator + radiograph), (3) Cleaning/shaping with Reciproc Blue R25 reciprocating files (VDW, Germany) using step-down technique, (4) Final irrigation: 3% NaOCl (5 mL per canal), EDTA (17%, 3 min), saline rinse

• CWC Group (EQ-V system, Meta Biomed, South Korea): (1) Master cone fit verified radiographically. (2) EQ-V cutting tip positioned 4-6 mm short of working length; cone tip trimmed 0.5-1 mm. (3) Master cone + sealer inserted: Heated plugger activated (230°C) to apical 4-6 mm compaction --> Hand plugger vertical condensation --> Thermoplasticized gutta-percha backfill --> Post-obturation radiograph
• SC Group: (1) Master cone fit verified radiographically. (2) Cone coated with sealer, seated to working length. (3) Excess gutta-percha is heat-trimmed at the orifice. (4) Post-obturation radiograph

Sealer: AH Plus (Dentsply Sirona) in both groups. Obturation time is measured from cone insertion to radiograph completion.

Outcome Assessments:

• Primary: 6-month success (European Society of Endodontology criteria: no symptoms + normal/reduced PDL space)

• Secondaries:

  • Obturation time (stopwatch, seconds)
  • Radiographic quality (length: adequate/short/long; voids; sealer extrusion; accessory canal filling)
  • Pain (NRS 0-10 at 4, 24, 48, 72 hours)

Assessor: Independent blinded evaluator (NTNV)

Follow-up: Patients are recalled at 6 months (±2 weeks) for clinical exam and radiograph. Success determined by absence of pain/swelling/sinus tract + radiographic healing.

Statistical Considerations:

Sample size calculated for 80% power (α=0.05, P1=89.5% vs P2=77.0% canal filling rates). Intention-to-treat analysis. Continuous data: independent t-tests. Categorical: chi-square/Fisher's exact. p<0.05 significant.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Hue
    • Huế, Hue, Vietnam, 49000
      • Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy, Hue University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CWC; Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill.	Procedure: Continuous Wave Condensation; 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)
Active Comparator: SC; Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess.	Procedure: Single-Cone; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of 6-month treatment success	clinical/radiographic per European Society of Endodontology criteria	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessment was performed per tooth (n=60) and per canal (n=193) by a blinded independent assessor. The length of canal filling was classified as adequate obturation length (Gutta-percha at radiographic apex or <2 mm short), underfilled (Gutta-percha >2 mm short of apex), or overfilled (Gutta-percha beyond radiographic apex).	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	The presence of voids within obturation material assessed by periapical radiograph is classified as: Void presence: Radiolucency observed within the obturation material; Void absence: No radiolucency detected	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	The apical sealer and gutta-percha extrusion, which extends beyond the radiographic apex, were assessed using a periapical radiograph and classified as yes/no extrusion.	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	Periapical radiographs assess the presence of gutta-percha filling in accessory/lateral canals, classifying it as yes/no accessory canal filling.	Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
Postoperative pain intensity assessed by Numeric Rating Scale (NRS 0-10)	Patient-reported pain severity on 11-point NRS (0=no pain, 10=worst imaginable pain). Assessed at four time points by patient diary.	4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation

Collaborators and Investigators

• Sponsor: Hue University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Endodontics; Pain Measurement; Root Canal Obturation; Gutta-Percha; Radiography, Detal
• Other Study ID Numbers: H2022/259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

As this study was completed prior to institutional data sharing policy implementation at Hue University of Medicine and Pharmacy, individual participant data (IPD) sharing is undecided. De-identified patient data includes sensitive clinical records (radiographs, pain scores, demographics) from a Vietnamese university hospital population.

Sharing requires Institutional Review Board (IRB) re-approval (H2022/259), participant re-consent (not obtained at enrollment), and Vietnamese Ministry of Health data protection compliance. Technical limitations include lack of standardized electronic health record format and absence of data use agreements with international repositories.

Researchers may contact the corresponding author (ntnvy@huemed-univ.edu.vn) to discuss potential collaboration. Aggregate results are fully reported in the primary publication. IPD sharing decisions will follow institutional policy updates and applicable regulations including GDPR-equivalent Vietnamese personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No