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

24 de abril de 2026 actualizado por: Nguyen Thi Nhat Vy, Hue University of Medicine and Pharmacy

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

56

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: CWC
Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill.

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)
Comparador activo: SC
Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess.
  • 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
The rate of 6-month treatment success
Periodo de tiempo: 6 months
clinical/radiographic per European Society of Endodontology criteria
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Obturation time
Periodo de tiempo: from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed)
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
Periodo de tiempo: Immediately post-obturation, within 5 minutes after the obturation procedure is completed.
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
Periodo de tiempo: Immediately post-obturation: within 5 minutes after the obturation procedure is completed.

The presence of voids within obturation material assessed by periapical radiograph is classified as:

  1. Void presence: Radiolucency observed within the obturation material
  2. 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
Periodo de tiempo: Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
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
Periodo de tiempo: Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
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)
Periodo de tiempo: 4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation
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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de junio de 2022

Finalización primaria (Actual)

1 de diciembre de 2024

Finalización del estudio (Actual)

1 de junio de 2025

Fechas de registro del estudio

Enviado por primera vez

15 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

1 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

1 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de abril de 2026

Última verificación

1 de diciembre de 2024

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • H2022/259

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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