Irreversible PulpitisNCT07562139
Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques
A study testing Continuous Wave Condensation and Single-Cone in people with Irreversible Pulpitis, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial 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: 1. Does continuous wave condensation differ from the single-cone technique in obturation time? 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Continuous Wave Condensation and Single-Cone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Teeth diagnosed with irreversible pulpitis
- Indicated for endodontic treatment
- Patients aged 18-60 years
Who cannot join
- 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
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- Internal or external resorption
- Calcified/C-shaped canals
- Canal curvature >70°
- Failures during canal preparation
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Faculty of Odonto-Stomatology, Hue University of Medicine and Pharmacy, Hue University
Huế, Hue, 49000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Irreversible Pulpitis
- Being tested
- Continuous Wave Condensation, Single-Cone
- Keywords
- Endodontics, Root Canal Obturation, Gutta-Percha, Pain Measurement, Radiography, Detal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Wave CondensationProcedure or surgery
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)
Single-ConeProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| CWC | Experimental | Continuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill. Receives: Procedure: Continuous Wave Condensation |
| SC | Active comparator | Single-Cone: Gutta-percha cone + sealer to working length, heat trim excess. Receives: Procedure: Single-Cone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of 6-month treatment success
clinical/radiographic per European Society of Endodontology criteria
Measured: 6 months
Secondary outcomes (6)
Obturation time
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jun 2022
- Primary completion1 Dec 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Thi Nhat Vy, Hue University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07562139
- Sponsor's protocol ID
- H2022/259
- Status last verified
- Dec 2024
- First submitted
- 15 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single-Visit Endodontic Treatment Outcomes Using Continuous Wave Condensation and Single-Cone Obturation Techniques: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07562139
- Acronym / sponsor ID
- H2022/259
- Conditions
- Irreversible Pulpitis
- Keywords
- Endodontics, Root Canal Obturation, Gutta-Percha, Pain Measurement, Radiography, Detal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CWC | Experimental | Procedure: Continuous Wave CondensationContinuous Wave Condensation (EQ-V system, Meta Biomed): Heated plugger at 230°C, apical compaction, thermoplastic backfill. |
| SC | Active comparator | Procedure: Single-ConeSingle-Cone: Gutta-percha cone + sealer to working length, heat trim excess. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Teeth diagnosed with irreversible pulpitis
- Indicated for endodontic treatment
- Patients aged 18-60 years
Key exclusion criteria (10 listed)
- Periapical/furcation lesions;
- Need for periodontal surgery
- Periodontal pockets ≥ 5 mm
- Adjacent teeth undergoing endodontic treatment
- Severely fractured or non-restorable crowns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Wave CondensationContinuous 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) | Procedure or surgery | CWC |
| 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 | Procedure or surgery | SC |
Primary outcome
The rate of 6-month treatment success
Time frame: 6 months
clinical/radiographic per European Society of Endodontology criteria
6 secondary outcomes
Obturation time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately post-obturation: within 5 minutes after the obturation procedure is completed.
Postoperative pain intensity assessed by Numeric Rating Scale (NRS 0-10)
Time frame: 4 hours post-obturation; 24 hours post-obturation; 48 hours post-obturation; 72 hours post-obturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Wave Condensation and Single-Cone in people with Irreversible Pulpitis, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of 6-month treatment success (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.