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

2026년 4월 24일 업데이트: 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.

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

56

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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)
활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The rate of 6-month treatment success
기간: 6 months
clinical/radiographic per European Society of Endodontology criteria
6 months

2차 결과 측정

결과 측정
측정값 설명
기간
Obturation time
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 6월 1일

기본 완료 (실제)

2024년 12월 1일

연구 완료 (실제)

2025년 6월 1일

연구 등록 날짜

최초 제출

2026년 4월 15일

QC 기준을 충족하는 최초 제출

2026년 4월 24일

처음 게시됨 (실제)

2026년 5월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 24일

마지막으로 확인됨

2024년 12월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • H2022/259

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

미정

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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