Symptomatic Irreversible Pulpitis (SIP)POP-RCTNCT07434141
Postoperative Pain After Single-Cone Root Canal Obturation Using Three Sealers
A study testing Endoseal TCS, Neosealer and AH Plus in people with Symptomatic Irreversible Pulpitis (SIP) and Symptomatic Irreversible Pulpitis With Apical Peridontitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this clinical trial is to compare post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis With Apical Peridontitis
- What is being tested?
- Endoseal TCS, Neosealer and AH Plus
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteIran
- Study dates
- 8 Jun 2025to 30 May 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 60 years
- Adequate oral and dental hygiene
- Prolonged positive response to cold test and electric pulp testing
- Clinical diagnosis of symptomatic irreversible pulpitis and symptomatic apical periodontitis in a first or second molar (maxillary or mandibular)
- Pulp exposure during caries removal accompanied by severe and profuse hemorrhage
- No radiographic evidence of periapical lesions
- Teeth with adequate restorative potential
- Absence of periodontal disease
Who cannot join
- Teeth that are non-restorable
- Presence of endodontic-periodontal (endo-perio) lesions
- Teeth with radiographic evidence of periapical lesions
- Teeth with internal or external root resorption
- Patients with systemic diseases classified as ASA II or higher
- Patients with a history of migraine
Show all 10Show fewer
- Teeth with over-obturation or under-obturation greater than 2 mm from the radiographic apex
- Patients taking anti-anxiety medications
- Procedural duration exceeding two hours
- Known allergy to materials used in root canal treatment, including local anesthetics
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tehran University of Medical Sciences, School of Dentistry
Tehran, 1439955991
About this study
Official title: Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial
The goal of this clinical trial is to compare post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment.
The main questions this study aims to answer are:
Read more
Does the type of root canal sealer affect the intensity of pain after treatment?
Does the type of sealer influence the number of analgesic tablets taken by participants?
How does pain change over time after treatment with different sealers?
Researchers will compare two bioceramic sealers (EndoSeal TCS and NeoSeal) with a resin-based sealer (AH Plus) to determine their effects on post-endodontic pain.
Participants will:
Receive root canal treatment using one of the study sealers
Report their pain intensity at specific time points after treatment
Record the number of analgesic tablets taken during the follow-up period
- Conditions
- Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis With Apical Peridontitis
- Being tested
- Endoseal TCS, Neosealer, AH Plus
- Keywords
- Post endodontic pain, Symptomatic irreversible pulpitis, Single cone obturation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoseal TCSProcedure or surgery
Bioceramic, premixed calcium silicate-based root canal sealer used for obturation with the single-cone technique during root canal treatment
NeosealerProcedure or surgery
Fast-setting calcium silicate-based bioceramic root canal sealer used for obturation with the single-cone technique during root canal treatment
AH PlusProcedure or surgery
Epoxy resin-based root canal sealer used for obturation with the single-cone technique during root canal treatment
| Study group | Role | What they receive |
|---|---|---|
| EndoSeal TCS | Experimental | Participants receive single-visit root canal treatment using the bioceramic sealer EndoSeal TCS with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals Receives: Procedure: Endoseal TCS |
| NeoSealer | Experimental | Participants receive single-visit root canal treatment using the bioceramic sealer NeoSealer with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals. Receives: Procedure: Neosealer |
| AH Plus | Experimental | Participants receive single-visit root canal treatment using the resin-based sealer AH Plus with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals Receives: Procedure: AH Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Endodontic Pain Intensity
Pain intensity experienced by participants after root canal treatment will be measured using a Visual Analog Scale (VAS; 0-10 numeric rating scale), where:
0 = no pain
10 = worst imaginable pain
Higher scores indicate greater pain intensity (worse outcome).
Participants will also record the number of analgesic tablets consumed during the first 48 hours after treatment.
The maximum VAS pain score recorded during the first 48 hours will be considered the primary outcome
Measured: Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment
Secondary outcomes (1)
Analgesic Consumption
Total number of analgesic tablets consumed by participants during the first 48 hours after treatment
Measured: Within 48 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start8 Jun 2025
- Primary completionApr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible Pulpitis (SIP)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shole Ghabraei, Professor, Principal investigator, Tehran university of medical science, school of dentistryHadi Assadian, Assistant Professor, Principal investigator, Tehran university of medical science, school of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434141
- Sponsor's protocol ID
- IR.TUMS.DENTISTRY.REC.1404.021
- Acronym
- POP-RCT
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 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 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Postoperative Pain in Symptomatic Irreversible Pulpitis Teeth Following Single Cone Obturation Using Three Different Sealers: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07434141
- Acronym / sponsor ID
- POP-RCT / IR.TUMS.DENTISTRY.REC.1404.021
- Conditions
- Symptomatic Irreversible Pulpitis (SIP), Symptomatic Irreversible Pulpitis With Apical Peridontitis
- Keywords
- Post endodontic pain, Symptomatic irreversible pulpitis, Single cone obturation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 8 Jun 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 25 Feb 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 post-treatment pain after root canal therapy in adults with irreversible pulpitis using different root canal sealers. The study will also evaluate the need for pain medication after treatment.
The main questions this study aims to answer are:
Does the type of root canal sealer affect the intensity of pain after treatment?
Does the type of sealer influence the number of analgesic tablets taken by participants?
How does pain change over time after treatment with different sealers?
Researchers will compare two bioceramic sealers (EndoSeal TCS and NeoSeal) with a resin-based sealer (AH Plus) to determine their effects on post-endodontic pain.
Participants will:
Receive root canal treatment using one of the study sealers
Report their pain intensity at specific time points after treatment
Record the number of analgesic tablets taken during the follow-up period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EndoSeal TCS | Experimental | Procedure: Endoseal TCSParticipants receive single-visit root canal treatment using the bioceramic sealer EndoSeal TCS with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals |
| NeoSealer | Experimental | Procedure: NeosealerParticipants receive single-visit root canal treatment using the bioceramic sealer NeoSealer with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals. |
| AH Plus | Experimental | Procedure: AH PlusParticipants receive single-visit root canal treatment using the resin-based sealer AH Plus with the single-cone obturation technique. Postoperative pain intensity and analgesic consumption are recorded at predefined time intervals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 and 60 years
- Adequate oral and dental hygiene
- Prolonged positive response to cold test and electric pulp testing
- Clinical diagnosis of symptomatic irreversible pulpitis and symptomatic apical periodontitis in a first or second molar (maxillary or mandibular)
- Pulp exposure during caries removal accompanied by severe and profuse hemorrhage
Key exclusion criteria (10 listed)
- Teeth that are non-restorable
- Presence of endodontic-periodontal (endo-perio) lesions
- Teeth with radiographic evidence of periapical lesions
- Teeth with internal or external root resorption
- Patients with systemic diseases classified as ASA II or higher
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 |
|---|---|---|
| Endoseal TCSBioceramic, premixed calcium silicate-based root canal sealer used for obturation with the single-cone technique during root canal treatment | Procedure or surgery | EndoSeal TCS |
| NeosealerFast-setting calcium silicate-based bioceramic root canal sealer used for obturation with the single-cone technique during root canal treatment | Procedure or surgery | NeoSealer |
| AH PlusEpoxy resin-based root canal sealer used for obturation with the single-cone technique during root canal treatment | Procedure or surgery | AH Plus |
Primary outcome
Post-Endodontic Pain Intensity
Time frame: Pain will be assessed at 6, 12,18, 24, and 48 hours post-treatment
Pain intensity experienced by participants after root canal treatment will be measured using a Visual Analog Scale (VAS; 0-10 numeric rating scale), where: 0 = no pain 10 = worst imaginable pain Higher scores indicate greater pain intensity (worse outcome). Participants will also record the number of analgesic tablets consumed during the first 48 hours after treatment. The maximum VAS pain score recorded during the first 48 hours will be considered the primary outcome
1 secondary outcome
Analgesic Consumption
Time frame: Within 48 hours post-treatment
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 25 Feb 2026.
- Individual participant dataSharing planned: Undecided
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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.
Shole Ghabraei, Professor principal investigator
Tehran university of medical science, school of dentistry
Hadi Assadian, Assistant Professor principal investigator
Tehran university of medical science, school of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoseal TCS, Neosealer and AH Plus in people with Symptomatic Irreversible Pulpitis (SIP) and Symptomatic Irreversible Pulpitis With Apical Peridontitis, run by Tehran University of Medical Sciences at 1 site in Iran.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 25 Feb 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 Iran. 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?
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?
Post-Endodontic Pain Intensity (time frame: Pain will be assessed at 6, 12,18, 24, and 48 hours 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 25 Feb 2026.