Necrotic PulpNCT07310212
Evaluation of Postoperative Pain and Success Rate Between Lateral Condensation and Warm Vertical Obturation Techniques
A study testing Warm Vertical Condensation (WVO) and Cold Lateral Condensation (CLC) in people with Necrotic Pulp and Asymptomatic Apical Periodontitis, run by University of Jordan at 1 site in Jordan.
Trial summary
Brief Summary Postoperative pain is a common complication following root canal treatment, particularly in necrotic teeth with asymptomatic apical periodontitis. Although obturation technique has been suggested as a contributing factor to postoperative discomfort, direct clinical comparisons between commonly used… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotic Pulp, Asymptomatic Apical Periodontitis
- What is being tested?
- Warm Vertical Condensation (WVO) and Cold Lateral Condensation (CLC)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteJordan
- Study dates
- 17 Oct 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older.
- Patients requiring endodontic treatment for single-rooted necrotic teeth.
- Radiographic and clinical diagnosis of asymptomatic apical periodontitis.
- Ability to understand the study and provide written informed consent.
Who cannot join
- Teeth diagnosed with symptomatic apical periodontitis.
- Pregnant or lactating women.
- Patients with systemic diseases affecting pain perception (e.g., uncontrolled diabetes, chronic pain conditions).
- Teeth that have been previously endodontically treated.
- Patients taking medications that may influence pain perception (e.g., chronic analgesic or anti-inflammatory drug use).
- Periodontally compromised teeth with significant bone loss or mobility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
University of Jordan Hospital
Amman, Amman Governate, 11942
Dalin Jihad AlSawafta, Endodontic Resident, DDs, +962779420787, dalin7495@gmail.com
About this study
Official title: Evaluation of Postoperative Pain and Success Rate Between Lateral Condensation and Warm Vertical Obturation Techniques - A Randomized Controlled Trial
Brief Summary
Postoperative pain is a common complication following root canal treatment, particularly in necrotic teeth with asymptomatic apical periodontitis. Although obturation technique has been suggested as a contributing factor to postoperative discomfort, direct clinical comparisons between commonly used methods remain limited. Cold lateral condensation has traditionally been considered the standard obturation technique, while warm vertical obturation systems such as Obtura II have gained popularity due to their potential for improved adaptation of gutta-percha.
This randomized controlled clinical trial aims to compare postoperative pain experience and treatment outcomes following cold lateral condensation and warm vertical obturation in single-rooted necrotic teeth. Postoperative pain will be assessed during the early healing period, along with patient-reported outcomes and short-term clinical and radiographic healing. The results of this study are expected to provide clinically relevant evidence to support evidence-based obturation technique selection and improve patient comfort in endodontic practice.
Read the detailed description
This study is a prospective, parallel-group randomized controlled clinical trial designed to investigate the influence of obturation technique on postoperative pain experience and short-term treatment outcomes in single-rooted teeth with necrotic pulps.
All endodontic treatments will be performed by a single experienced operator to minimize inter-operator variability. After administration of local anesthesia and placement of rubber dam isolation, standardized access cavities will be prepared. Working length determination will be performed using an electronic apex locator and confirmed radiographically.
Root canal preparation will be carried out using rotary nickel-titanium instruments according to a standardized instrumentation protocol applied uniformly across all participants. Irrigation will be standardized for all cases and will include sodium hypochlorite during instrumentation and ethylenediaminetetraacetic acid (EDTA) for smear layer removal, followed by final canal irrigation and drying using sterile paper points. All procedural steps prior to obturation will be identical between groups to isolate the effect of obturation technique on postoperative outcomes.
Participants will be randomly assigned to one of two obturation techniques:
- Cold lateral condensation, performed using standardized gutta-percha cones and an epoxy resin-based sealer.
- Warm vertical condensation, performed using a thermoplasticized gutta-percha delivery system (Obtura II) in combination with gutta-percha and the same sealer.
Obturation procedures will be conducted according to manufacturer instructions and established clinical guidelines. Immediate coronal sealing will be completed following obturation to reduce the risk of coronal microleakage.
Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will receive standardized written and verbal instructions on how to record pain intensity at predefined time points following treatment. Analgesic consumption during the postoperative period will also be documented. Follow-up contact will be made as needed to ensure adherence to pain recording and study protocols.
Clinical and radiographic evaluations will be performed at baseline and at a 6-month follow-up visit to assess treatment outcome and periapical healing. Standardized periapical radiographs will be obtained using consistent exposure parameters. Radiographic assessment will be performed by a blinded assessor to reduce assessment bias.
Randomization will be carried out using sealed opaque envelopes prepared prior to patient recruitment. Due to the nature of the intervention, operator blinding is not feasible; however, patients will be blinded to the obturation technique used, and outcome assessment will be performed by blinded evaluators whenever applicable.
This study is designed to generate controlled clinical evidence regarding the effect of obturation technique on postoperative pain perception and short-term treatment outcomes in necrotic single-rooted teeth, thereby supporting evidence-based clinical decision-making in endodontic practice.
- Conditions
- Necrotic Pulp, Asymptomatic Apical Periodontitis
- Being tested
- Warm Vertical Condensation (WVO), Cold Lateral Condensation (CLC)
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warm Vertical Condensation (WVO)Procedure or surgery
Following standard endodontic cleaning and shaping with rotary instrumentation and irrigation, canals will be obturated using the warm vertical condensation technique. After placement of a master cone coated with AH Plus sealer, heat is applied to soften and vertically compact the gutta-percha within the canal. The Obtura II system will be used to backfill the canal with thermoplasticized gutta-percha, ensuring three-dimensional adaptation and dense filling of the root canal space.
Cold Lateral Condensation (CLC)Procedure or surgery
Following standard endodontic cleaning and shaping with rotary instrumentation and irrigation, canals will be obturated using the cold lateral condensation technique. A master gutta-percha cone coated with sealer (AH Plus) will be inserted, and accessory cones will be compacted laterally using spreaders until the canal is fully obturated. This technique is widely regarded as the traditional standard method for root canal obturation.
| Study group | Role | What they receive |
|---|---|---|
| Warm vertical obturation | Active comparator | Not described Receives: Procedure: Warm Vertical Condensation (WVO) |
| Cold lateral condensation obturation | Experimental | Not described Receives: Procedure: Cold Lateral Condensation (CLC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity following two different obturation techniques
Visual Analog Scale (VAS), 0-10 0 represents no pain, 10 represents excruciating pain
Measured: Baseline (6 hours post-treatment), 12 hours post-treatment,1 day, 2 days, 3 days, 4 days, and daily up to 7 days post-treatment
Secondary outcomes (3)
Patient Satisfaction
Questionnaire:
Extremely satisfied Satisfied Neutral Dissatisfied Extremely dissatisfied
The maximum is extremely satisfied The minimum is extremely dissatisfied
Measured: Immediately after treatment6 months post treatment
Assess the need for pain medication
Yes/no
The check wether or not the patient needed painkillers If yes what time
'They were advised to take ibupren 400 mg in case of pain and to record when did they need it''
Measured: 6 hours post treatment12 hours post treatment1 day2 days3 days4 days up to the complete resolution of pain
Evaluation of diffrence in success rate
Comparing Periapical radiographs
Measured: Immediately After treatment 6 months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start17 Oct 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies 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
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalin Al Sawaftah, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310212
- Sponsor's protocol ID
- 224000393
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2025
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain and Success Rate Between Lateral Condensation and Warm Vertical Obturation Techniques - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07310212
- Acronym / sponsor ID
- 224000393
- Conditions
- Necrotic Pulp, Asymptomatic Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
Brief Summary
Postoperative pain is a common complication following root canal treatment, particularly in necrotic teeth with asymptomatic apical periodontitis. Although obturation technique has been suggested as a contributing factor to postoperative discomfort, direct clinical comparisons between commonly used methods remain limited. Cold lateral condensation has traditionally been considered the standard obturation technique, while warm vertical obturation systems such as Obtura II have gained popularity due to their potential for improved adaptation of gutta-percha.
This randomized controlled clinical trial aims to compare postoperative pain experience and treatment outcomes following cold lateral condensation and warm vertical obturation in single-rooted necrotic teeth. Postoperative pain will be assessed during the early healing period, along with patient-reported outcomes and short-term clinical and radiographic healing. The results of this study are expected to provide clinically relevant evidence to support evidence-based obturation technique selection and improve patient comfort in endodontic practice.
Detailed description
This study is a prospective, parallel-group randomized controlled clinical trial designed to investigate the influence of obturation technique on postoperative pain experience and short-term treatment outcomes in single-rooted teeth with necrotic pulps.
All endodontic treatments will be performed by a single experienced operator to minimize inter-operator variability. After administration of local anesthesia and placement of rubber dam isolation, standardized access cavities will be prepared. Working length determination will be performed using an electronic apex locator and confirmed radiographically.
Root canal preparation will be carried out using rotary nickel-titanium instruments according to a standardized instrumentation protocol applied uniformly across all participants. Irrigation will be standardized for all cases and will include sodium hypochlorite during instrumentation and ethylenediaminetetraacetic acid (EDTA) for smear layer removal, followed by final canal irrigation and drying using sterile paper points. All procedural steps prior to obturation will be identical between groups to isolate the effect of obturation technique on postoperative outcomes.
Participants will be randomly assigned to one of two obturation techniques:
- Cold lateral condensation, performed using standardized gutta-percha cones and an epoxy resin-based sealer.
- Warm vertical condensation, performed using a thermoplasticized gutta-percha delivery system (Obtura II) in combination with gutta-percha and the same sealer.
Obturation procedures will be conducted according to manufacturer instructions and established clinical guidelines. Immediate coronal sealing will be completed following obturation to reduce the risk of coronal microleakage.
Postoperative pain will be assessed using a Visual Analog Scale (VAS). Participants will receive standardized written and verbal instructions on how to record pain intensity at predefined time points following treatment. Analgesic consumption during the postoperative period will also be documented. Follow-up contact will be made as needed to ensure adherence to pain recording and study protocols.
Clinical and radiographic evaluations will be performed at baseline and at a 6-month follow-up visit to assess treatment outcome and periapical healing. Standardized periapical radiographs will be obtained using consistent exposure parameters. Radiographic assessment will be performed by a blinded assessor to reduce assessment bias.
Randomization will be carried out using sealed opaque envelopes prepared prior to patient recruitment. Due to the nature of the intervention, operator blinding is not feasible; however, patients will be blinded to the obturation technique used, and outcome assessment will be performed by blinded evaluators whenever applicable.
This study is designed to generate controlled clinical evidence regarding the effect of obturation technique on postoperative pain perception and short-term treatment outcomes in necrotic single-rooted teeth, thereby supporting evidence-based clinical decision-making in endodontic practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warm vertical obturation | Active comparator | Procedure: Warm Vertical Condensation (WVO) |
| Cold lateral condensation obturation | Experimental | Procedure: Cold Lateral Condensation (CLC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Patients requiring endodontic treatment for single-rooted necrotic teeth.
- Radiographic and clinical diagnosis of asymptomatic apical periodontitis.
- Ability to understand the study and provide written informed consent.
Key exclusion criteria (6 listed)
- Teeth diagnosed with symptomatic apical periodontitis.
- Pregnant or lactating women.
- Patients with systemic diseases affecting pain perception (e.g., uncontrolled diabetes, chronic pain conditions).
- Teeth that have been previously endodontically treated.
- Patients taking medications that may influence pain perception (e.g., chronic analgesic or anti-inflammatory drug use).
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 |
|---|---|---|
| Warm Vertical Condensation (WVO)Following standard endodontic cleaning and shaping with rotary instrumentation and irrigation, canals will be obturated using the warm vertical condensation technique. After placement of a master cone coated with AH Plus sealer, heat is applied to soften and vertically compact the gutta-percha within the canal. The Obtura II system will be used to backfill the canal with thermoplasticized gutta-percha, ensuring three-dimensional adaptation and dense filling of the root canal space. | Procedure or surgery | Warm vertical obturation |
| Cold Lateral Condensation (CLC)Following standard endodontic cleaning and shaping with rotary instrumentation and irrigation, canals will be obturated using the cold lateral condensation technique. A master gutta-percha cone coated with sealer (AH Plus) will be inserted, and accessory cones will be compacted laterally using spreaders until the canal is fully obturated. This technique is widely regarded as the traditional standard method for root canal obturation. | Procedure or surgery | Cold lateral condensation obturation |
Primary outcome
Postoperative pain intensity following two different obturation techniques
Time frame: Baseline (6 hours post-treatment), 12 hours post-treatment,1 day, 2 days, 3 days, 4 days, and daily up to 7 days post-treatment
Visual Analog Scale (VAS), 0-10 0 represents no pain, 10 represents excruciating pain
3 secondary outcomes
Patient Satisfaction
Time frame: Immediately after treatment6 months post treatment
Assess the need for pain medication
Time frame: 6 hours post treatment12 hours post treatment1 day2 days3 days4 days up to the complete resolution of pain
Evaluation of diffrence in success rate
Time frame: Immediately After treatment 6 months posttreatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Necrotic Pulp
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruiting
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Pulp Necrosis, Apical Periodontitis
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Influence of Continuous Rotation Versus Reciprocation Motion of MG3 Blue Rotary File on Postoperative Pain and Intracanal Bacterial Reduction of Teeth With Necrotic Pulps.
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Conventional and Nano-Metronidazole Irrigation With/Without Activation in Necrotic Teeth With Apical Periodontitis
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Warm Vertical Condensation (WVO) and Cold Lateral Condensation (CLC) in people with Necrotic Pulp and Asymptomatic Apical Periodontitis, run by University of Jordan at 1 site in Jordan.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 2 Apr 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 Jordan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dalin Jihad AlSawaftah, Endodontic resident, DDs (+962779420787, dalin7495@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity following two different obturation techniques (time frame: Baseline (6 hours post-treatment), 12 hours post-treatment,1 day, 2 days, 3 days, 4 days, and daily up to 7 days post-treatment). 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 2 Apr 2026.