Periapical PeriodontitisNCT07018284
Postoperative Pain Evaluation After Obturation With Different Sealers
A study testing AH Plus (Dentsply Sirona, Charlotte, NC, USA), NeoSealer Flo and Continuous Wave Condensation in people with Periapical Periodontitis and Pulpitis, run by University of Siena at 1 site in Spain.
Trial summary
This study aims to evaluate the incidence and intensity of postoperative pain in patients undergoing root canal treatment on teeth diagnosed with pulpitis, pulp necrosis, or with previous endodontic treatment. Teeth will be obturated using either bioceramic or resin-based sealers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Periodontitis, Pulpitis, Necorsis
- What is being tested?
- AH Plus (Dentsply Sirona, Charlotte, NC, USA), NeoSealer Flo and Continuous Wave Condensation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2025to 30 Jan 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
- Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. Informed consent provided for data usage.
Who cannot join
- Patients with systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunosuppression).
- Asymptomatic presentation
- Teeth with root fractures, resorption, or open apices.
- Incomplete clinical or radiographic records.
- Cases with poor-quality radiographs or lack of standardization for evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad Rey Juan Carlos , Madrid, Spain 28922
Madrid, 28922
Jose Aranguren, MsC, Spain: +34 617352993, josearanguren@hotmail.com
About this study
Official title: Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers
This study aims to evaluate the incidence and intensity of postoperative pain in patients undergoing root canal treatment on teeth diagnosed with pulpitis, pulp necrosis, or with previous endodontic treatment. Teeth will be obturated using either bioceramic or resin-based sealers. The primary objective is to determine whether the type of sealer significantly influences the level of postoperative pain as reported by patients. Pain intensity will be assessed using the Visual Analogue Scale (VAS) at three time points: immediately after treatment, 24 hours, and 72 hours postoperatively. The findings are expected to provide clinical insight into which obturation material may be more effective in minimizing postoperative discomfort.
- Conditions
- Periapical Periodontitis, Pulpitis, Necorsis
- Being tested
- AH Plus (Dentsply Sirona, Charlotte, NC, USA), NeoSealer Flo, Continuous Wave Condensation, Single Cone Technique
- Keywords
- Bioceramic sealers, Resin-based sealers, Endodontics
- Medical subject headings
- Periapical Periodontitis, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH Plus (Dentsply Sirona, Charlotte, NC, USA)Procedure or surgery
Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA), a resin-based sealer with low solubility and shrinkage. Used in combination with gutta-percha for root canal filling
NeoSealer FloProcedure or surgery
Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA), a premixed bioceramic sealer based on calcium silicate. Used in combination with gutta-percha to enhance apical healing and biocompatibility.
Continuous Wave CondensationProcedure or surgery
A warm vertical compaction technique using heat-softened gutta-percha to obturate the canal in three dimensions. Considered the gold standard for achieving dense and homogenous root canal fillings.
Single Cone TechniqueProcedure or surgery
A cold hydraulic condensation technique using a single gutta-percha cone matched to the last rotary file, combined with a high-flow sealer. Designed for simplified obturation with minimal operator variability
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: AH Plus + Continuous Wave Condensation | Active comparator | Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA) and the continuous wave technique with thermoplasticized gutta-percha Receives: Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA); Procedure: Continuous Wave Condensation |
| Active Comparator: AH Plus + Single Cone | Experimental | Root canal obturation using AH Plus and the single cone technique with cold gutta-percha. Receives: Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA); Procedure: Single Cone Technique |
| NeoSealer Flo + Continuous Wave | Experimental | Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique. Receives: Procedure: NeoSealer Flo; Procedure: Continuous Wave Condensation |
| NeoSealer Flo + Single Cone | Experimental | Root canal obturation using NeoSealer Flo and the single cone technique. Receives: Procedure: NeoSealer Flo; Procedure: Single Cone Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Success Based on Periapical Index (PAI) Criteria
Radiographic outcome will be assessed using the Periapical Index (PAI) by Ørstavik et al. (1986), which categorizes periapical healing from 1 (normal periapical structures) to 5 (severe apical periodontitis). Success is defined as PAI scores of 1 or 2 (complete healing or healing in progress). Evaluations will be based on periapical radiographs (and CBCT when available) taken at follow-up after at least 6 months. The assessment will be performed by a calibrated blinded evaluator using reference radiographs.
Measured: Minimum 6 months after root canal treatment
Secondary outcomes (2)
Clinical Success Based on Absence of Symptoms
Clinical success will be defined by the absence of pain, tenderness to percussion or palpation, swelling, mobility, and other signs of persistent infection. These parameters will be evaluated through standard clinical examination during follow-up visits.
Measured: Minimum 6 months after treatment
Radiographic Success Based on CBCT Evaluation
When available, cone beam computed tomography (CBCT) images will be used to assess periapical healing. A modified periapical index (PAI-CBCT) will be used, evaluating the presence, size, and resolution of periapical radiolucencies. Lesion healing will be interpreted as success if there is full resolution or significant reduction in size compared to baseline.
Measured: Minimum 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jun 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical PeriodontitisStudies 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, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Principal investigator, Simone Grandini, University of Siena
- Investigators
- José Aranguren, MsC, Study director, Universidad Rey Juan Carlos , Madrid, Spain 28922Simone Grandini, PhD, Principal investigator, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07018284
- Sponsor's protocol ID
- HSCO
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain Incidence in Teeth Affected by Pulpitis, Necrosis, or Previously Treated, Following Obturation With Bioceramic or Resin-based Sealers
- ClinicalTrials.gov ID
- NCT07018284
- Acronym / sponsor ID
- HSCO
- Conditions
- Periapical Periodontitis, Pulpitis, Necorsis
- Keywords
- Bioceramic sealers, Resin-based sealers, Endodontics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 12 Jun 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.
This study aims to evaluate the incidence and intensity of postoperative pain in patients undergoing root canal treatment on teeth diagnosed with pulpitis, pulp necrosis, or with previous endodontic treatment. Teeth will be obturated using either bioceramic or resin-based sealers. The primary objective is to determine whether the type of sealer significantly influences the level of postoperative pain as reported by patients. Pain intensity will be assessed using the Visual Analogue Scale (VAS) at three time points: immediately after treatment, 24 hours, and 72 hours postoperatively. The findings are expected to provide clinical insight into which obturation material may be more effective in minimizing postoperative discomfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: AH Plus + Continuous Wave Condensation | Active comparator | Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA), Procedure: Continuous Wave CondensationRoot canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA) and the continuous wave technique with thermoplasticized gutta-percha |
| Active Comparator: AH Plus + Single Cone | Experimental | Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA), Procedure: Single Cone TechniqueRoot canal obturation using AH Plus and the single cone technique with cold gutta-percha. |
| NeoSealer Flo + Continuous Wave | Experimental | Procedure: NeoSealer Flo, Procedure: Continuous Wave CondensationRoot canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique. |
| NeoSealer Flo + Single Cone | Experimental | Procedure: NeoSealer Flo, Procedure: Single Cone TechniqueRoot canal obturation using NeoSealer Flo and the single cone technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. Informed consent provided for data usage.
Key exclusion criteria (5 listed)
- Patients with systemic conditions that may impair healing (e.g., uncontrolled diabetes, immunosuppression).
- Asymptomatic presentation
- Teeth with root fractures, resorption, or open apices.
- Incomplete clinical or radiographic records.
- Cases with poor-quality radiographs or lack of standardization for evaluation
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 |
|---|---|---|
| AH Plus (Dentsply Sirona, Charlotte, NC, USA)Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA), a resin-based sealer with low solubility and shrinkage. Used in combination with gutta-percha for root canal filling | Procedure or surgery | Active Comparator: AH Plus + Continuous Wave Condensation, Active Comparator: AH Plus + Single Cone |
| NeoSealer FloRoot canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA), a premixed bioceramic sealer based on calcium silicate. Used in combination with gutta-percha to enhance apical healing and biocompatibility. | Procedure or surgery | NeoSealer Flo + Continuous Wave, NeoSealer Flo + Single Cone |
| Continuous Wave CondensationA warm vertical compaction technique using heat-softened gutta-percha to obturate the canal in three dimensions. Considered the gold standard for achieving dense and homogenous root canal fillings. | Procedure or surgery | Active Comparator: AH Plus + Continuous Wave Condensation, NeoSealer Flo + Continuous Wave |
| Single Cone TechniqueA cold hydraulic condensation technique using a single gutta-percha cone matched to the last rotary file, combined with a high-flow sealer. Designed for simplified obturation with minimal operator variability | Procedure or surgery | Active Comparator: AH Plus + Single Cone, NeoSealer Flo + Single Cone |
Primary outcome
Radiographic Success Based on Periapical Index (PAI) Criteria
Time frame: Minimum 6 months after root canal treatment
Radiographic outcome will be assessed using the Periapical Index (PAI) by Ørstavik et al. (1986), which categorizes periapical healing from 1 (normal periapical structures) to 5 (severe apical periodontitis). Success is defined as PAI scores of 1 or 2 (complete healing or healing in progress). Evaluations will be based on periapical radiographs (and CBCT when available) taken at follow-up after at least 6 months. The assessment will be performed by a calibrated blinded evaluator using reference radiographs.
2 secondary outcomes
Clinical Success Based on Absence of Symptoms
Time frame: Minimum 6 months after treatment
Radiographic Success Based on CBCT Evaluation
Time frame: Minimum 6 months 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 12 Jun 2025.
- Individual participant dataSharing planned: Undecided
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A Retrospective Cohort Study on the Non-Surgical Treatment of Periapical Inflammatory Lesions With Vitapex Paste
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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.
José Aranguren, MsC study director
Universidad Rey Juan Carlos , Madrid, Spain 28922
Simone Grandini, PhD principal investigator
University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AH Plus (Dentsply Sirona, Charlotte, NC, USA), NeoSealer Flo and Continuous Wave Condensation in people with Periapical Periodontitis and Pulpitis, run by University of Siena at 1 site in Spain.
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 1 inclusion and 5 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 12 Jun 2025. 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 Spain. 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 Giulia Malvicini, DDS (Italia: +39 3487200168, giulia.malvicini@student.unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Success Based on Periapical Index (PAI) Criteria (time frame: Minimum 6 months after root canal 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 12 Jun 2025.