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:
- Does continuous wave condensation differ from the single-cone technique in obturation time?
- 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Hue
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Huế, Hue, Viêt Nam, 49000
- Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy, Hue University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: CWC
Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill.
|
Continuous Wave Condensation (CWC) - Specific Protocol:
|
|
Comparateur actif: SC
Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess.
|
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The rate of 6-month treatment success
Délai: 6 months
|
clinical/radiographic per European Society of Endodontology criteria
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Obturation time
Délai: from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed)
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from insertion of master gutta-percha cone with sealer until completion of obturation procedure (final condensation/backfill completed)
|
|
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Percentage of canals with adequate obturation length (±2 mm from radiographic apex) assessed by periapical radiograph
Délai: 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.
|
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Percentage of canals/tooth with the presence of voids (radiolucency within filling material) assessed by periapical radiograph
Délai: 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:
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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
Délai: Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
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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.
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Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
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Percentage of tooth with the presence of gutta-percha filling in accessory/lateral canals assessed by periapical radiograph
Délai: Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
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Periapical radiographs assess the presence of gutta-percha filling in accessory/lateral canals, classifying it as yes/no accessory canal filling.
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Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
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Postoperative pain intensity assessed by Numeric Rating Scale (NRS 0-10)
Délai: 4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation
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Patient-reported pain severity on 11-point NRS (0=no pain, 10=worst imaginable pain).
Assessed at four time points by patient diary.
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4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- H2022/259
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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
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