Root Canal ObturationNCT04753138
Outcome of SBO With Calcium Silicate Sealer vs WVC With Resin Based Sealer
A study testing TotalFill Bioceramic Sealer and AH+ Sealer in people with Root Canal Obturation and Root Canal Filling, run by Kuwait Institute for Medical Specialization at 1 site in Kuwait.
Trial summary
A single blinded randomized controlled trial. 212 subjects (teeth), 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Root Canal Obturation, Root Canal Filling, Sealer-based Obturation
- What is being tested?
- TotalFill Bioceramic Sealer and AH+ Sealer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteKuwait
- Study dates
- 24 Feb 2021to 3 Dec 2023
- 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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- All types of permanent teeth are included (incisors, canines, premolars \& molars)
- The teeth must be restorable and have fully formed roots with no advanced periodontal disease
- In the event that a patient has more than 1 tooth eligible for the study, only one tooth on the left and/or right side of the mouth will be selected at random. A maximum of 2 teeth per participant can be included in the study
Who cannot join
- ASA classification of III or more
- Pregnant women
- Advanced periodontal disease or teeth with more than 5mm probing
- Teeth with incomplete root formation or root resorption
- Teeth with adjacent teeth that require RCT
- Previously root canal treated teeth
Show all 10Show fewer
- Teeth with a history of trauma
- Teeth that have poor restorative prognosis
- Teeth requiring extensive prosthodontic rehabilitation
- Cracked teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Outcome of Non-surgical Root Canal Treatment Using Sealer-based Obturation With Calcium Silicate Sealer vs. Warm Vertical Compaction With AH+ Sealer. A Randomized Controlled Clinical Trial
A single blinded randomized controlled trial. 212 subjects (teeth), 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment. The aim is to compare the outcome of sealer-based obturation (SBO) with calcium silicate sealer versus warm vertical compaction (WVC) and resin based sealer.
Preoperative PA radiograph and CBCT will be taken. A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken. The preoperative, postoperative and review clinical and radiographic data will be analyzed
Read the detailed description
Aims and Objectives
- To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment.
- To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans.
- To assess the difference in postoperative pain between the 2 groups.
- To assess the difference in the time required to complete the obturation between the 2 groups.
Materials and Methods
- Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusion/exclusion criteria of the study will be included
- Pre-operative periapical radiograph, CBCT scan and 11-point Numerical Rating Scale (NRS) will be taken.
- Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: obturation using SCCS or Group B: obturation using WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canal/canals are ready for obturation.
- All teeth will then be restored definitively.
- The participants will be contacted via telephone 1, 3 and 7 days post-treatment to report their NRS pain score.
- The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan.
- The participants will then be followed-up annually for up to 4 years.
- Statistical analysis will be performed.
- The design of the study will conform to the CONSORT statement.
Statistical and Analytical Plans
Sample size estimation for the treatment outcome was performed using PASS 2019 computer software, utilizing information from previous studies on healing outcome after initial endodontic therapy. For a two independent-samples t-test of proportions, at power of 80% and 5% significance level for two-tailed test, detecting a 10% difference of healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size was 212 teeth. The slightly high 30% dropout rate is anticipated because most of the patients we treat are non-Kuwaiti nationals and their presence in the country after 1 year is not guaranteed.
- Conditions
- Root Canal Obturation, Root Canal Filling, Sealer-based Obturation, Randomized Clinical Trial, Postoperative Pain, Resin Based Sealer
- Being tested
- TotalFill Bioceramic Sealer, AH+ Sealer
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TotalFill Bioceramic SealerDevice
It will be used in conjunction with TotalFill® bioceramic impregnated gutta percha points for the obturation of root canals. It is dispensed through a fine disposable syringe into the root canals during obturation.
AH+ SealerDevice
It consists of 2 pastes that are mixed together in equal amounts before it is used in conjunction with gutta percha points for obturation during root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| SBO with calcium silicate sealer | Experimental | The teeth will be obturated with the single cone technique and BC sealer Receives: Device: TotalFill Bioceramic Sealer |
| WVC with resin based sealer | Active comparator | The teeth will be obturated with warm vertical compaction and AH+ sealer Receives: Device: AH+ Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of radiographic healing with periapical (PA) radiographs using Orstavik's PAI
Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits). Orstavik's periapical index (PAI) will be used as the outcome measure
Measured: Comparison of of periapical lesion size at baseline and 12 months
Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT
Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits). Estrela's (periapical index) PAI based on CBCT will be used as outcome measure
Measured: Comparison of 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
Secondary outcomes (2)
Comparison of the postoperative pain score
11 point Numerical Rating Scale (NRS) will be used. The participants will be given an NRS sheet to complete. They will be asked to choose a number between 0 'No Pain' and 10 'Worst imaginable pain' that best represents your pain intensity.
Measured: 1, 3 and 7 days postoperatively
Comparison of the time required to complete obturation between the 2 groups
Measured: Intra-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start24 Feb 2021
- Primary completion3 Dec 2023
- Study completion3 Dec 2023
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 ObturationStudies 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 (of block size = only known to statistician) will be used to randomly select 212 subjects (106 subjects in each group). Statistical software (NCSS, LLC© ver. 2020) will be utilized to generate the randomization list and subjects will be assigned to the selected treatment group accordingly.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait Institute for Medical Specialization
- Sponsor type
- Other government
- Collaborators
- Ministry of Health, Kuwait, Kuwait Foundation for the Advancement of Sciences
- Responsible party
- Principal investigator, Fahad Alzoubi, Kuwait Institute for Medical Specialization
- Investigators
- Fahad Alzoubi, M.Endo, Principal investigator, Kuwait Board of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753138
- Sponsor's protocol ID
- Fahadmz
- Status last verified
- Dec 2023
- First submitted
- 26 Jan 2021
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alzoubi F, Alajmi S, Alkandari A, Alqahtani S, Alanezi A, Setzer FC. Post-operative pain in non-surgical root canal treatment after sealer-based obturation versus warm vertical compaction: A randomized clinical trial. Int Endod J. 2024 Sep;57(9):1168-1179. doi: 10.1111/iej.14102. Epub 2024 May 30.
PubMed 38813933
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Non-surgical Root Canal Treatment Using Sealer-based Obturation With Calcium Silicate Sealer vs. Warm Vertical Compaction With AH+ Sealer. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04753138
- Acronym / sponsor ID
- Fahadmz
- Conditions
- Root Canal Obturation, Root Canal Filling, Sealer-based Obturation, Randomized Clinical Trial, Postoperative Pain, Resin Based Sealer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Kuwait Institute for Medical SpecializationOther government
- Collaborators
- Ministry of Health, Kuwait, Kuwait Foundation for the Advancement of Sciences
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 3 Dec 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 15 Feb 2021 (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.
A single blinded randomized controlled trial. 212 subjects (teeth), 106 in each of the 2 groups will be recruited from the patients referred to Kuwait Board of Endodontics for primary root canal treatment. The aim is to compare the outcome of sealer-based obturation (SBO) with calcium silicate sealer versus warm vertical compaction (WVC) and resin based sealer.
Preoperative PA radiograph and CBCT will be taken. A 1 year follow up period will be arranged and another PA radiograph and CBCT will be taken. The preoperative, postoperative and review clinical and radiographic data will be analyzed
Detailed description
Aims and Objectives
- To compare the clinical outcome of the SBO with WVC in non-surgical root canal treatment.
- To compare the radiographic outcome of the SBO with WVC in non-surgical root canal treatment using periapical radiographs and CBCT scans.
- To assess the difference in postoperative pain between the 2 groups.
- To assess the difference in the time required to complete the obturation between the 2 groups.
Materials and Methods
- Patients who are referred to the Kuwait Board of Endodontics for non-surgical root canal treatment and fulfil the inclusion/exclusion criteria of the study will be included
- Pre-operative periapical radiograph, CBCT scan and 11-point Numerical Rating Scale (NRS) will be taken.
- Upon completion of root canal instrumentation, the participants will be randomly allocated to either Group A: obturation using SCCS or Group B: obturation using WVC. The participants will be blinded to the type of treatment received and the clinician will only be informed of the obturation method once the canal/canals are ready for obturation.
- All teeth will then be restored definitively.
- The participants will be contacted via telephone 1, 3 and 7 days post-treatment to report their NRS pain score.
- The participants will be recalled after 1 year for clinical and radiographic assessment using periapical radiograph and CBCT scan.
- The participants will then be followed-up annually for up to 4 years.
- Statistical analysis will be performed.
- The design of the study will conform to the CONSORT statement.
Statistical and Analytical Plans
Sample size estimation for the treatment outcome was performed using PASS 2019 computer software, utilizing information from previous studies on healing outcome after initial endodontic therapy. For a two independent-samples t-test of proportions, at power of 80% and 5% significance level for two-tailed test, detecting a 10% difference of healing rate required a sample size of 148 teeth. Adjusting for a dropout rate of 30%, the required sample size was 212 teeth. The slightly high 30% dropout rate is anticipated because most of the patients we treat are non-Kuwaiti nationals and their presence in the country after 1 year is not guaranteed.
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 (of block size = only known to statistician) will be used to randomly select 212 subjects (106 subjects in each group). Statistical software (NCSS, LLC© ver. 2020) will be utilized to generate the randomization list and subjects will be assigned to the selected treatment group accordingly.
| Arm | Type | Receives |
|---|---|---|
| SBO with calcium silicate sealer | Experimental | Device: TotalFill Bioceramic SealerThe teeth will be obturated with the single cone technique and BC sealer |
| WVC with resin based sealer | Active comparator | Device: AH+ SealerThe teeth will be obturated with warm vertical compaction and AH+ sealer |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- All types of permanent teeth are included (incisors, canines, premolars \& molars)
- The teeth must be restorable and have fully formed roots with no advanced periodontal disease
Key exclusion criteria (10 listed)
- ASA classification of III or more
- Pregnant women
- Advanced periodontal disease or teeth with more than 5mm probing
- Teeth with incomplete root formation or root resorption
- Teeth with adjacent teeth that require RCT
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 |
|---|---|---|
| TotalFill Bioceramic SealerIt will be used in conjunction with TotalFill® bioceramic impregnated gutta percha points for the obturation of root canals. It is dispensed through a fine disposable syringe into the root canals during obturation. | Device | SBO with calcium silicate sealer |
| AH+ SealerIt consists of 2 pastes that are mixed together in equal amounts before it is used in conjunction with gutta percha points for obturation during root canal treatment. | Device | WVC with resin based sealer |
Primary outcome
Assessment of radiographic healing with periapical (PA) radiographs using Orstavik's PAI
Time frame: Comparison of of periapical lesion size at baseline and 12 months
Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits). Orstavik's periapical index (PAI) will be used as the outcome measure
Assessment of radiographic healing with Cone beam computed tomography (CBCT) scans using Estrela's PAI based on CBCT
Time frame: Comparison of of periapical lesion size at baseline and 12 months
Proportion t-test will be carried to compare the proportion of study subjects with improved apical lesion size between the two treatment groups. Odds ratio with 95% confidence interval will be reported. Logistic regression analysis adjusted for the stratification variables (gender) and other confounding factors (namely patency, extrusion of sealer or GP, short fill, voids, pre-op apical size, pre-op clinical symptoms and number of C\&S visits). Estrela's (periapical index) PAI based on CBCT will be used as outcome measure
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)
2 secondary outcomes
Comparison of the postoperative pain score
Time frame: 1, 3 and 7 days postoperatively
Comparison of the time required to complete obturation between the 2 groups
Time frame: Intra-operatively
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 3 Jan 2024.
- Derived from this study: PubMed 38813933Alzoubi F, Alajmi S, Alkandari A, Alqahtani S, Alanezi A, Setzer FC. Post-operative pain in non-surgical root canal treatment after sealer-based obturation versus warm vertical compaction: A randomized clinical trial. Int Endod J. 2024 Sep;57(9):1168-1179. doi: 10.1111/iej.14102. Epub 2024 May 30.
Related trials for Root Canal Obturation
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
Recruiting
Clinical and Radiographic Evaluation of E-IodoCal in Primary Molar Pulpectomy
Pulpectomy, Pulpitis - Irreversible
Not yet recruiting
Assessment of Postoperative Pain Following Root Canal Obturation of Permanent Mature Teeth Using Three Different Obturation Techniques: A Randomized Clinical Trial
Postoperative Pain
Not yet recruiting
Effects of Different Root Canal Filling Materials and Irrigation Agitation Techniques on Postoperative Pain in Teeth With Irreversible Pulpitis: A Randomized Clinical Trial
Postoperative Pain After Endodontic Treatment, Oral Health-Related Quality of Life
Recruiting
Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers
Pain
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.
Fahad Alzoubi, M.Endo principal investigator
Kuwait Board of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TotalFill Bioceramic Sealer and AH+ Sealer in people with Root Canal Obturation and Root Canal Filling, run by Kuwait Institute for Medical Specialization 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 6 inclusion and 10 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 3 Jan 2024. 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 periapical (PA) radiographs using Orstavik's PAI (time frame: Comparison of of periapical lesion size at baseline and 12 months). The study lists 3 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 NCT04753138, 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 3 Jan 2024.