Root Canal InfectionNCT05763420
Sealer-Based Obturation With AH Plus Bioceramic Sealer vs. Warm Vertical Compaction With AH Plus
A study testing AH Plus Bioceramic Sealer and AH Plus Sealer (resin-based) in people with Root Canal Infection and Periapical Periodontitis, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Infection, Periapical Periodontitis, Periapical Diseases
- What is being tested?
- AH Plus Bioceramic Sealer and AH Plus Sealer (resin-based)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 1 siteKuwait
- Study dates
- 7 Aug 2023to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be 18-65 years of age at the time of recruitment
- Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
- Participants must not have known allergies to any materials used in the study
- Participants must agree to participate in the study by signing a consent form
- Participants must have good oral hygiene
- Maxillary and mandibular permanent molar teeth that require primary root canal treatment will be included
- The teeth must be restorable and have fully formed roots with no advanced periodontal disease
Who cannot join
- ASA classification of III or more
- Pregnant or breastfeeding women
- Patients who are unable to give consent
- Patients who have advanced periodontal disease or teeth with more than 5mm probing
- Anterior, premolar and third molar teeth
- Teeth whose apices were over-enlarged at the time of pulp extirpation
Show all 15Show fewer
- Teeth with broken instruments
- Teeth with blocked or non-negotiable canals
- Teeth with iatrogenic perforations
- Teeth with incomplete root formation
- Teeth with internal or external root resorption
- Teeth that have a poor restorative prognosis
- Teeth that require posts or extensive prosthetic rehabilitation
- Teeth with cracks
- Teeth that have been previously root-filled
Trial locations and contacts
1 site in 1 country.
Kuwait1 site
Jaber Al-Ahmed Dental Center
Janūb as Surrah, Hawalli Governate, 00000
About this study
Official title: Outcome of Sealer-Based Obturation With AH Plus Bioceramic Sealer Versus Warm Vertical Compaction With AH Plus: A CBCT-Based Randomised Controlled Non-Inferiority Trial
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.
Read the detailed description
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:
- To compare the clinical outcome of single-cone bioceramic obturation (SBO) with warm vertical compaction (WVC) in primary root canal treatment.
- To compare the radiographic outcome of SBO and WVC using periapical (PA) radiographs and cone-beam computed tomography (CBCT).
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.
- Being tested
- AH Plus Bioceramic Sealer, AH Plus Sealer (resin-based)
- Medical subject headings
- Periapical Periodontitis, Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH Plus Bioceramic SealerDevice
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.
AH Plus Sealer (resin-based)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| SBO with AH Plus Bioceramic Sealer | Experimental | The teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer. Receives: Device: AH Plus Bioceramic Sealer |
| WVC with resin-based AH Plus Sealer | Active comparator | The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer. Receives: Device: AH Plus Sealer (resin-based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Change from baseline at 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start7 Aug 2023
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal InfectionStudies 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
- Model description
- Permuted block randomization using a block size of 4 will be used to randomly select 156 participants (78 participants in each group). The Study Randomizer website (http://www.studyrandomizer.com) will be utilized to generate the randomization list and participants will be assigned to the selected treatment group accordingly.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Kuwait
- Sponsor type
- Other government
- Collaborators
- Kuwait Institute for Medical Specialization
- Responsible party
- Principal investigator, Ahmed Aldowaisan, Ministry of Health, Kuwait
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763420
- Sponsor's protocol ID
- 2291
- Status last verified
- Oct 2026
- First submitted
- 27 Feb 2023
- Last updated
- 9 Oct 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Sealer-Based Obturation With AH Plus Bioceramic Sealer Versus Warm Vertical Compaction With AH Plus: A CBCT-Based Randomised Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT05763420
- Acronym / sponsor ID
- 2291
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Collaborators
- Kuwait Institute for Medical Specialization
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 10 Mar 2023 (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.
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.
Detailed description
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:
- To compare the clinical outcome of single-cone bioceramic obturation (SBO) with warm vertical compaction (WVC) in primary root canal treatment.
- To compare the radiographic outcome of SBO and WVC using periapical (PA) radiographs and cone-beam computed tomography (CBCT).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Permuted block randomization using a block size of 4 will be used to randomly select 156 participants (78 participants in each group). The Study Randomizer website (http://www.studyrandomizer.com) will be utilized to generate the randomization list and participants will be assigned to the selected treatment group accordingly.
| Arm | Type | Receives |
|---|---|---|
| SBO with AH Plus Bioceramic Sealer | Experimental | Device: AH Plus Bioceramic SealerThe teeth will be obturated using a single cone technique with AH Plus Bioceramic Sealer. |
| WVC with resin-based AH Plus Sealer | Active comparator | Device: AH Plus Sealer (resin-based)The teeth will be obturated using warm vertical compaction with resin-based AH Plus Sealer. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be 18-65 years of age at the time of recruitment
- Participants must have a classification of I or II on the American Society of Anesthesiologists (ASA) physical status classification system
- Participants must not have known allergies to any materials used in the study
- Participants must agree to participate in the study by signing a consent form
- Participants must have good oral hygiene
Key exclusion criteria (15 listed)
- ASA classification of III or more
- Pregnant or breastfeeding women
- Patients who are unable to give consent
- Patients who have advanced periodontal disease or teeth with more than 5mm probing
- Anterior, premolar and third molar teeth
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 Bioceramic SealerA 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. | Device | SBO with AH Plus Bioceramic Sealer |
| AH Plus Sealer (resin-based)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. | Device | WVC with resin-based AH Plus Sealer |
Primary outcome
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
Time frame: Change from baseline periapical lesion size at 12-24 months
Estrela's PAI based on CBCT will be used in logistic regression models with different predictor variables.
Assessment of clinical outcome by assessing the resolution/persistence/development of clinical signs and symptoms
Time frame: Change from baseline at 12-24 months
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Bioceramic Sealer and AH Plus Sealer (resin-based) in people with Root Canal Infection and Periapical Periodontitis, run by Ministry of Health, Kuwait at 1 site in Kuwait.
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 7 inclusion and 15 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: finished, as of the sponsor's last update on 9 Oct 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 Kuwait. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index) (time frame: Change from baseline periapical lesion size at 12-24 months). 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 9 Oct 2026.