Post Operative Pain, AcuteNCT07923110
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
A study testing A calcium silicate-based sealer and An epoxy resin- based sealer in people with Post Operative Pain, Acute and Irreversible Pulpitis (Toothache), run by University Ghent at 1 site in Belgium.
Trial summary
When the nerve inside a tooth becomes inflamed, it can cause severe pain and may eventually lead to the death of the nerve. In these cases, root canal treatment is necessary to remove the inflamed nerve or to treat or prevent infection associated with a dead nerve. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain, Acute, Irreversible Pulpitis (Toothache), Pulp Necrosis, Apical Periodontitis
- What is being tested?
- A calcium silicate-based sealer and An epoxy resin- based sealer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2026to Aug 2029
- 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
- Written informed consent obtained
- Age: ≥ 18 years
- ASA I, II \& III
- Permanent single or multi-rooted mature tooth requiring root-canal treatment
- Diagnosis: (a)symptomatic irreversible pulpitis or pulp necrosis, with or without apical periodontitis or initially treated
Who cannot join
- Unlikely to be able to comply with the study procedures, as judged by the investigator
- Immature permanent teeth
- Teeth presenting with aberrant root canal anatomy (e.g., perforation, resorption or canal calcification)
- Patients presenting with pain in another area and/or tooth of the oral cavity
- Patient suffering from uncontrolled active periodontitis
- Patients who took medication that could alter pain perception (e.g. analgesics) within at least 12 h before treatment
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- Known or suspected current malignancy
- History of chemotherapy within 5 years prior to study or radiation in the head and neck region
- History of other metabolic bone diseases
- Endodontic retreatment (ortho-and retrograde), reversible pulpitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
UZ Gent
Ghent, 9000
Prof. Dr. Mieke De Bruyne, +3293324020, Mieke.DeBruyne@uzgent.be
About this study
Official title: Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer: a Randomized Clinical Trial
When the nerve inside a tooth becomes inflamed, it can cause severe pain and may eventually lead to the death of the nerve. In these cases, root canal treatment is necessary to remove the inflamed nerve or to treat or prevent infection associated with a dead nerve.
During root canal treatment, the root canals are carefully cleaned and then filled. This is usually done using a flexible, rubber-like material called gutta-percha, combined with a special dental cement known as a root canal sealer.
Different types of root canal sealers are available, including AH Plus and BioRoot Flow. The aim of this study is to compare these two sealers to determine whether there are differences in pain experienced after treatment and in treatment success, assessed during follow-up visits after 1 and 2 years.
- Conditions
- Post Operative Pain, Acute, Irreversible Pulpitis (Toothache), Pulp Necrosis, Apical Periodontitis
- Being tested
- A calcium silicate-based sealer, An epoxy resin- based sealer
- Medical subject headings
- Pain, Postoperative, Toothache, Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A calcium silicate-based sealerDevice
Root canal obturation is performed using the single-cone technique, in which a gutta-percha cone is inserted into the root canal in combination with a calcium silicate-based sealer: BioRoot Flow
An epoxy resin- based sealerDevice
Root canal obturation is performed using the single-cone technique, in which a gutta-percha cone is inserted into the root canal in combination with an epoxy resin-based sealer: AH Plus Jet
| Study group | Role | What they receive |
|---|---|---|
| A calcium silicate-based sealer | Active comparator | Not described Receives: Device: A calcium silicate-based sealer |
| An epoxy resin- based sealer | Experimental | Not described Receives: Device: An epoxy resin- based sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
The post-operative pain is scored with the Visual Analogue Scale (VAS). Patients are asked to fill out a pain diary 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment with a pain score on the Visual Analogue Scale. They mark the level of pain on a scale from 0 to 10. Higher scores indicate greater pain intensity.
Measured: 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
Treatment outcome
The 1 and 2 year success rates are determined using a combination of radiographic and clinical outcome measures.
- Clinical: The absence of pain, tenderness, swelling and a sinus tract)
- Radiographic: The pre-operative and recall periapical radiographs are assessed qualitatively by means of the Periapical Index (PAI) and quantitatively by means of surface area measurements of the APs on periapical radiographs.
The two aforementioned outcomes will be combined to determine overall treatment success, which will be classified into three categories:
- Strict success criteria (healed): Absence of clinical signs and/or radiographic evidence of complete resolution or the absence of a periapical radiolucency.
- Loose success criteria (healing): Absence of clinical signs and a lower PAI-score/ smaller surface of the lesion compared to the pre-operative radiograph.
- Failure (non-healing): Presence of clinical signs or unchanged/increased PAI-score (or surface of the lesion) at follow-up.
Measured: up to 2 years following treatment
Secondary outcomes (2)
Quality of obturation
The root canal obturation is evaluated on peri-apical radiograph on the presence of voids. First is stated if a void was present (Yes/No). If so, a distinction is made whether the void was smaller or bigger than 1 mm.
Measured: Immediately after treatment
Sealer extrusion
The presence of sealer extrusion beyond the apical foramen is evaluated as a binary outcome (Yes/No).
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923110
- Sponsor's protocol ID
- ONZ-2026-0209
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07923110
- Acronym / sponsor ID
- ONZ-2026-0209
- Conditions
- Post Operative Pain, Acute, Irreversible Pulpitis (Toothache), Pulp Necrosis, Apical Periodontitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 6 Nov 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.
When the nerve inside a tooth becomes inflamed, it can cause severe pain and may eventually lead to the death of the nerve. In these cases, root canal treatment is necessary to remove the inflamed nerve or to treat or prevent infection associated with a dead nerve.
During root canal treatment, the root canals are carefully cleaned and then filled. This is usually done using a flexible, rubber-like material called gutta-percha, combined with a special dental cement known as a root canal sealer.
Different types of root canal sealers are available, including AH Plus and BioRoot Flow. The aim of this study is to compare these two sealers to determine whether there are differences in pain experienced after treatment and in treatment success, assessed during follow-up visits after 1 and 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A calcium silicate-based sealer | Active comparator | Device: A calcium silicate-based sealer |
| An epoxy resin- based sealer | Experimental | Device: An epoxy resin- based sealer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent obtained
- Age: ≥ 18 years
- ASA I, II \& III
- Permanent single or multi-rooted mature tooth requiring root-canal treatment
- Diagnosis: (a)symptomatic irreversible pulpitis or pulp necrosis, with or without apical periodontitis or initially treated
Key exclusion criteria (10 listed)
- Unlikely to be able to comply with the study procedures, as judged by the investigator
- Immature permanent teeth
- Teeth presenting with aberrant root canal anatomy (e.g., perforation, resorption or canal calcification)
- Patients presenting with pain in another area and/or tooth of the oral cavity
- Patient suffering from uncontrolled active periodontitis
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 |
|---|---|---|
| A calcium silicate-based sealerRoot canal obturation is performed using the single-cone technique, in which a gutta-percha cone is inserted into the root canal in combination with a calcium silicate-based sealer: BioRoot Flow | Device | A calcium silicate-based sealer |
| An epoxy resin- based sealerRoot canal obturation is performed using the single-cone technique, in which a gutta-percha cone is inserted into the root canal in combination with an epoxy resin-based sealer: AH Plus Jet | Device | An epoxy resin- based sealer |
Primary outcome
Post-operative pain
Time frame: 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment
The post-operative pain is scored with the Visual Analogue Scale (VAS). Patients are asked to fill out a pain diary 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment with a pain score on the Visual Analogue Scale. They mark the level of pain on a scale from 0 to 10. Higher scores indicate greater pain intensity.
Treatment outcome
Time frame: up to 2 years following treatment
The 1 and 2 year success rates are determined using a combination of radiographic and clinical outcome measures. * Clinical: The absence of pain, tenderness, swelling and a sinus tract) * Radiographic: The pre-operative and recall periapical radiographs are assessed qualitatively by means of the Periapical Index (PAI) and quantitatively by means of surface area measurements of the APs on periapical radiographs. The two aforementioned outcomes will be combined to determine overall treatment success, which will be classified into three categories: * Strict success criteria (healed): Absence of clinical signs and/or radiographic evidence of complete resolution or the absence of a periapical radiolucency. * Loose success criteria (healing): Absence of clinical signs and a lower PAI-score/ smaller surface of the lesion compared to the pre-operative radiograph. * Failure (non-healing): Presence of clinical signs or unchanged/increased PAI-score (or surface of the lesion) at follow-up.
2 secondary outcomes
Quality of obturation
Time frame: Immediately after treatment
Sealer extrusion
Time frame: Immediately after 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 6 Nov 2026.
- Individual participant dataSharing planned: No
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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 A calcium silicate-based sealer and An epoxy resin- based sealer in people with Post Operative Pain, Acute and Irreversible Pulpitis (Toothache), run by University Ghent at 1 site in Belgium.
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 5 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: opening soon, as of the sponsor's last update on 6 Nov 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 Belgium. 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 Prof. Dr. Mieke De bruyne (+3293324020, Mieke.DeBruyne@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 6 hours, 24 hours, 48 hours, 72 hours and 7 days after treatment). The study lists 2 primary outcomes in all. 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 6 Nov 2026.