An interventional study of AH Plus (Dentsply Sirona, Charlotte, NC, USA) and NeoSealer Flo in Pulpitis, Periapical Lesions and Periapical Periodontitis, sponsored by University of Siena. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by University of Siena · Not applicable, Interventional, and Treatment
The present study aims to compare the radiographic success of endodontic treatment using Orstavik's criteria between two sealers: AH Plus (Dentsply DeTrey, Konstanz, Germany) and Neosealer Flo (Avalon Biomed, Bradenton, Florida, USA), as well as between two obturation techniques: continuous wave and single cone. The study includes 270 patients, with a minimum follow-up period of 6 months. Clinical and radiographic variables will be assessed, including quality of obturation, lesion healing, and restoration. The study seeks to determine if the use of bioceramic sealer is effective regardless of the obturation technique used, highlighting the importance of clinical follow-up to evaluate endodontic treatment success.
316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.
This study's planned enrollment of 270 is above the median of 64 across 288 interventional studies indexed under Pulpitis.
Browse Pulpitis studies →University of Siena is the lead sponsor of 65 studies on the registry; 15 are open to participants now.
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Patients aged 18 years and older. Teeth with a diagnosis of pulpal necrosis or irreversible pulpitis. provided for data usage.
Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Root canal obturation using AH Plus (Dentsply Sirona, Charlotte, NC, USA) and the continuous wave technique with thermoplasticized gutta-percha
Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA) · Procedure: Continuous Wave Condensation
Root canal obturation using AH Plus and the single cone technique with cold gutta-percha.
Procedure: AH Plus (Dentsply Sirona, Charlotte, NC, USA) · Procedure: Single Cone Technique
Root canal obturation using NeoSealer Flo (Avalon Biomed, Houston, TX, USA) and the continuous wave technique.
Procedure: NeoSealer Flo · Procedure: Continuous Wave Condensation
Root canal obturation using NeoSealer Flo and the single cone technique.
Procedure: NeoSealer Flo · Procedure: Single Cone Technique
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.
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.
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.
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.
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.
Time frame: Minimum 6 months after root canal treatment
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.
Time frame: 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.
Time frame: Minimum 6 months after treatment
Plan to share: Undecided
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Started Jun 2025 (actual). Primary completion is estimated for Jan 2026, 7 months after the start.
Of 158 non-industry interventional studies with no phase under Pulpitis, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 28. This study's planned 7 months is below that.
Counting every sponsor, half of 158 studies reached it within 16 months; a quarter within 9 and three quarters within 28.
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University of Siena