An interventional study of A calcium silicate-based sealer and An epoxy resin- based sealer in Post Operative Pain, Acute, Irreversible Pulpitis (Toothache) and Pulp Necrosis, Apical Periodontitis, sponsored by University Ghent. Not yet recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University Ghent · Not applicable, Interventional, and Treatment
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.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 138 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →University Ghent is the lead sponsor of 350 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: A calcium silicate-based sealer
Device: An epoxy resin- based sealer
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
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
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.
Time frame: 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.
Time frame: up to 2 years following treatment
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.
Time frame: Immediately after treatment
Sealer extrusion
The presence of sealer extrusion beyond the apical foramen is evaluated as a binary outcome (Yes/No).
Time frame: Immediately after treatment
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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