Root Canal InfectionNCT05714384
Calcium Silicate Sealer-based Obturation in Root Canal Retreatment
An observational study of Root Canal Infection and Periapical Diseases, run by Ministry of Health, Kuwait at 1 site in Kuwait.
Trial summary
This study will evaluate the outcome of calcium silicate sealer-based obturations in root canal retreatment. 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 Diseases
- What is being tested?
- CeraSeal (Calcium Silicate-based Root Canal Sealer)
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 1 siteKuwait
- Study dates
- 5 Mar 2023to 31 Dec 2025
- Phase
- Observational
- 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
Study population: Patients who present with symptomatic teeth and require root canal retreatment will be assessed based on inclusion and exclusion criteria.
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
- All types of permanent teeth that require root canal retreatment are included (incisors, canines, premolars \& molars)
- 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
- Teeth with incomplete root formation
- Teeth that have a poor restorative prognosis
Show all 14Show fewer
- Teeth presenting with signs of a vertical root fracture
- Teeth with blocked or non-negotiable canals
- Teeth with broken instruments
- Teeth with iatrogenic perforations
- Teeth requiring posts or extensive prosthetic rehabilitation
- Teeth with cracks
- Teeth with internal or external root resorption
- Teeth with uncontrollable exudate
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 Calcium Silicate Sealer-based Obturation in Root Canal Retreatment: A CBCT-based Prospective Cohort Study
This study will evaluate the outcome of calcium silicate sealer-based obturations in root canal retreatment.
Read the detailed description
Calcium silicate sealer-based obturations have shown promising performance in primary root canal treatments, but there is a lack of prospective studies evaluating their effectiveness in secondary root canal treatments, which often involve more persistent microbial challenges. The aim of this study is to assess the clinical and radiographic outcomes of calcium silicate sealer-based obturations in root canal retreatment and to identify potential prognostic factors for healing.
Objectives:
- To determine the success rate of calcium silicate sealer-based obturations in root canal retreatment.
- To compare the observed outcomes with previously published retreatment studies using conventional obturation techniques.
- To identify potential prognostic factors associated with favourable or unfavourable outcomes.
This will be a prospective cohort study conducted at Jaber Al-Ahmed Dental Center. Informed written consent will be obtained from all participants. All nonsurgical root canal retreatments will be performed by a specialist endodontist using a calcium silicate-based sealer (CeraSeal, Meta Biomed) following current evidence-based standards. Treatments will be recorded in a secure database, and all cases will be followed for a minimum of 12 months.
Clinical and radiographic records will be reviewed, and eligibility will be determined according to predefined inclusion and exclusion criteria. All patient data will be anonymized before extraction and analysis.
The primary outcome at 12 months will be the proportion of teeth classified as having a favourable outcome. This outcome will serve as the dependent variable in logistic regression models evaluating the associations between healing and potential predictors, including age, sex, tooth type, periapical status, preoperative pain, quality of the previous root filling, sinus tracts, apical patency, final apical preparation size, and sealer extrusion. Separate univariable logistic regression models will be performed for each predictor. A multivariable logistic regression model will then be constructed to evaluate the combined effects of independent variables, with exploratory assessment of two-way interactions.
This study was designed as a single-arm prospective outcome investigation with the primary endpoint being the proportion of teeth exhibiting a favourable outcome. A precision-based approach was used to determine the required sample size. An anticipated healing rate of 80 percent was assumed based on systematic reviews and prospective cohort studies that report healing rates between 77 and 87 percent for nonsurgical retreatment.
Using PASS (version 25.0.3; NCSS, LLC, Kaysville, Utah, USA) with the One Proportion - Confidence Interval procedure (two-sided 95 percent confidence level, Wilson method), a sample size of 95 teeth was required to estimate the healing proportion with a target precision of approximately ±8 percentage points. Allowing for up to 30 percent attrition, the planned enrolment was set at 136 teeth, which is expected to yield at least 95 evaluable cases. This target aligns with sample sizes used in previous prospective clinical studies on endodontically retreated teeth.
- Conditions
- Root Canal Infection, Periapical Diseases
- Being tested
- CeraSeal (Calcium Silicate-based Root Canal Sealer)
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeraSeal (Calcium Silicate-based Root Canal Sealer)Device
A calcium silicate-based root canal sealer will be used in cases requiring root canal retreatment.
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: Comparison of periapical lesion size at baseline and 12 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: Comparison at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start5 Mar 2023
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 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
- NCT05714384
- Sponsor's protocol ID
- 2238
- Status last verified
- May 2026
- First submitted
- 26 Jan 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers.
Publications
Aldowaisan A, Alzoubi F, Alenezi M, Alqahtani S, Alajmi S, Amir F, Mannocci F. Outcome of Calcium Silicate Sealer-Based Obturation in Root Canal Retreatment: A CBCT-Based Prospective Cohort Study. Int Endod J. 2026 Aug 7. doi: 10.1111/iej.70252. Online ahead of print.
PubMed 42568232
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Calcium Silicate Sealer-based Obturation in Root Canal Retreatment: A CBCT-based Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05714384
- Acronym / sponsor ID
- 2238
- Conditions
- Root Canal Infection, Periapical Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Ministry of Health, KuwaitOther government
- Collaborators
- Kuwait Institute for Medical Specialization
- Study start
- 5 Mar 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 6 Feb 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.
This study will evaluate the outcome of calcium silicate sealer-based obturations in root canal retreatment.
Detailed description
Calcium silicate sealer-based obturations have shown promising performance in primary root canal treatments, but there is a lack of prospective studies evaluating their effectiveness in secondary root canal treatments, which often involve more persistent microbial challenges. The aim of this study is to assess the clinical and radiographic outcomes of calcium silicate sealer-based obturations in root canal retreatment and to identify potential prognostic factors for healing.
Objectives:
- To determine the success rate of calcium silicate sealer-based obturations in root canal retreatment.
- To compare the observed outcomes with previously published retreatment studies using conventional obturation techniques.
- To identify potential prognostic factors associated with favourable or unfavourable outcomes.
This will be a prospective cohort study conducted at Jaber Al-Ahmed Dental Center. Informed written consent will be obtained from all participants. All nonsurgical root canal retreatments will be performed by a specialist endodontist using a calcium silicate-based sealer (CeraSeal, Meta Biomed) following current evidence-based standards. Treatments will be recorded in a secure database, and all cases will be followed for a minimum of 12 months.
Clinical and radiographic records will be reviewed, and eligibility will be determined according to predefined inclusion and exclusion criteria. All patient data will be anonymized before extraction and analysis.
The primary outcome at 12 months will be the proportion of teeth classified as having a favourable outcome. This outcome will serve as the dependent variable in logistic regression models evaluating the associations between healing and potential predictors, including age, sex, tooth type, periapical status, preoperative pain, quality of the previous root filling, sinus tracts, apical patency, final apical preparation size, and sealer extrusion. Separate univariable logistic regression models will be performed for each predictor. A multivariable logistic regression model will then be constructed to evaluate the combined effects of independent variables, with exploratory assessment of two-way interactions.
This study was designed as a single-arm prospective outcome investigation with the primary endpoint being the proportion of teeth exhibiting a favourable outcome. A precision-based approach was used to determine the required sample size. An anticipated healing rate of 80 percent was assumed based on systematic reviews and prospective cohort studies that report healing rates between 77 and 87 percent for nonsurgical retreatment.
Using PASS (version 25.0.3; NCSS, LLC, Kaysville, Utah, USA) with the One Proportion - Confidence Interval procedure (two-sided 95 percent confidence level, Wilson method), a sample size of 95 teeth was required to estimate the healing proportion with a target precision of approximately ±8 percentage points. Allowing for up to 30 percent attrition, the planned enrolment was set at 136 teeth, which is expected to yield at least 95 evaluable cases. This target aligns with sample sizes used in previous prospective clinical studies on endodontically retreated teeth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who present with symptomatic teeth and require root canal retreatment will be assessed based on inclusion and exclusion criteria.
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 (14 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
- Teeth with incomplete root formation
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 |
|---|---|---|
| CeraSeal (Calcium Silicate-based Root Canal Sealer)A calcium silicate-based root canal sealer will be used in cases requiring root canal retreatment. | Device | – |
Primary outcome
Assessment of radiographic healing with cone beam computed tomography (CBCT) scans using Estrela's PAI (periapical index)
Time frame: Comparison of periapical lesion size at baseline and 12 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: Comparison at baseline and 12 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 26 May 2026.
- Derived from this study: PubMed 42568232Aldowaisan A, Alzoubi F, Alenezi M, Alqahtani S, Alajmi S, Amir F, Mannocci F. Outcome of Calcium Silicate Sealer-Based Obturation in Root Canal Retreatment: A CBCT-Based Prospective Cohort Study. Int Endod J. 2026 Aug 7. doi: 10.1111/iej.70252. Online ahead of print.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers.
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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?
An observational study of Root Canal Infection and Periapical Diseases, 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 14 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 26 May 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: Comparison of periapical lesion size at baseline and 12 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?
On the ClinicalTrials.gov record for NCT05714384, which also lists 1 linked publication.
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 26 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.