An interventional study of AH Plus Bioceramic Sealer and AH Plus Sealer (resin-based) in Root Canal Infection, Periapical Periodontitis and Periapical Diseases, sponsored by Ministry of Health, Kuwait. Completed at 1 site in Kuwait. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Ministry of Health, Kuwait · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to assess the efficacy and outcome of sealer-based obturation (SBO) using a new calcium silicate sealer in comparison with warm vertical compaction (WVC) using a resin-based sealer, which is the current gold standard.
Calcium silicate sealers are used in endodontics because of their biocompatibility, bioactivity, and their ability to form a hydroxyapatite-mediated interfacial bond with root canal dentine. Although in vitro and retrospective clinical studies have reported promising findings, there remains a lack of prospective, well-controlled trials evaluating their clinical and radiographic performance.
Aims and Objectives:
Materials and Methods:
Patients referred for primary root canal treatment of molar teeth at Jaber Al-Ahmed Dental Center who fulfil the inclusion and exclusion criteria will be invited to participate. Written informed consent will be obtained from all participants.
Preoperative PA radiographs and CBCT scans will be taken. After completion of root canal instrumentation, participants will be randomly allocated to either Group A: SBO or Group B: WVC. Participants will be blinded to the obturation technique. Allocation will remain concealed until canals are ready for obturation, at which time the treating clinician will be informed of the assigned method.
All teeth will receive definitive restorations following obturation. Participants will be recalled at 12-24 months for clinical and radiographic evaluation using PA radiographs and CBCT, and will subsequently be followed annually for up to 5 years.
The study will conform to the CONSORT statement and will be conducted in accordance with the Declaration of Helsinki. Ethical approval has been granted by the local health authority (ID: 2291).
Statistical and Analytical Plan:
The sample size was determined for a non-inferiority comparison of the primary success proportion between the treatment group (AH Plus Bioceramic Sealer) and the reference group. Assuming a reference-group success proportion of 92%, a non-inferiority margin of 13 percentage points (δ₀ = -0.13), and no true difference between groups under the alternative hypothesis (δ₁ = 0), a one-sided, two-sample Z-test with unpooled variance at a significance level of 0.05 required 54 evaluable participants per group (108 in total) to achieve 80% power. To account for an anticipated attrition rate of 30%, the enrollment target was inflated to 78 participants per group (156 in total), applying the formula N' = N / (1 - 0.30). All calculations were performed using PASS (NCSS, LLC, Kaysville, UT, USA).
Healing at 12-24 months will serve as the dependent variable in logistic regression models. Predictor variables will include age, sex, preoperative status, presence of apical periodontitis, preoperative pain, patency, apical preparation size, root filling quality, and sealer type. Two-way interactions will be assessed. Analyses will follow the intention-to-treat principle.
Null Hypothesis:
H₀: There is no difference between SBO and WVC in clinical or radiographic healing outcomes at 12-24 months.
280 studies on the registry are indexed under Periapical Periodontitis; 79 are open to participants now.
This study's enrollment of 156 is above the median of 60 across 245 interventional studies indexed under Periapical Periodontitis.
Browse Periapical Periodontitis studies →Ministry of Health, Kuwait is the lead sponsor of 15 studies on the registry; 5 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.
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.
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.
The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer.
Device: AH Plus Bioceramic Sealer
The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer.
Device: AH Plus Sealer (resin-based)
A bioactive, calcium silicate-based sealer will be used in combination with the core root canal filling material (gutta-percha). It's premixed and is dispensed in the root canal via a fine disposable syringe.
A resin-based sealer will be used in combination with the core root canal material (gutta-percha). It consists of two pastes that are mixed together in equal amounts prior to application.
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
Time frame: Change from baseline periapical lesion size at 12-24 months
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
The examiner will label the teeth as having a normal clinical outcome (absence of pain, swelling and other symptoms, no sinus tract, no loss of function) or showing signs and symptoms clinical outcome (the tooth is associated with signs and/or symptoms of infection).
Time frame: Change from baseline at 12-24 months
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 ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Kuwait