Root Canal ObturationNCT03732170
Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer
A study testing TotalFill® Bioceramic sealer and AH plus® sealer in people with Root Canal Obturation, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
The study design is a double blinded randomized controlled trial and 170 subjects (teeth) , 85 in each of the 2 groups, will be enrolled from the patients at the NUH dental centre endodontic unit. Read more about this study
- Who is it for?
- Ages 21 to 95 years
- Conditions the study is for
- Root Canal Obturation
- What is being tested?
- TotalFill® Bioceramic sealer and AH plus® sealer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Aug 2018to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A preoperative periapical radiograph will be required for diagnosis.
- Subjects at least 21 years old.
- Medically healthy
- In a patient with multiple teeth requiring root canal treatment, only 1 tooth from each side will be included and selected at random.
Who cannot join
- Patient below 21 years old
- Pregnant women.
- Patients with autoimmune diseases and uncontrolled diabetes.
- Teeth with periodontal probing depths of 5mm or more.
- Incomplete root formation that is detected radiographically.
- Cracked teeth
- Teeth are deemed to have poor restorative prognosis.
- Teeth with adjacent teeth on the same side that require root canal treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Outcome of Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer: A Randomized Controlled Trial
The study design is a double blinded randomized controlled trial and 170 subjects (teeth) , 85 in each of the 2 groups, will be enrolled from the patients at the NUH dental centre endodontic unit. The study aims to assess how the use of TotalFill® bioceramic sealer affects the healing outcome of apical periodontitis compared to a control AH plus®.
Conventional root canal treatment will be done during this study. Radiographs will be taken at each study visit during the study for root canal. The preoperative, postoperative and review clinical and radiographic data will be analysed.
Read the detailed description
Randomization and Blinding Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups. Allocation will be by random permuted block and stratified by gender to enhance balance. Computer generated randomized allocation for each subject will be concealed in opaque envelope. The envelope will only be opened by the operator on the obturation visit of the enrolled patient and the randomization number assigned to them.
In the event that a patient has more than 1 tooth eligible for the study, only one tooth on left and/or right side of the mouth will be recruited for the study. Therefore, a patient could contribute a maximum of two teeth for this study (i.e. a maximum of one tooth on each side of the mouth). Selection of tooth will be done using computer generated randomization number.
Study Visits and Procedures After cleaning and shaping and the patients are deemed ready for obturation, the patients will be randomly assigned to one of the 2 groups for obturation using AH plus® or TotalFill® bioceramic sealer.
- The patients and the examiners will be blinded to the type of sealer used but it would not be possible to blind the operators.
- Post Study Follow up and Procedures
- A follow up phone call will be made to collect the patient pain experience on day 1, day 3 and day 7 post treatment which they have recorded on their pain/discomfort diary.
- At the 6-month and 12-month review, patients will be examined for any clinical signs and symptoms and a review radiograph will be taken to assess the size of the periapical lesion.
- Radiographic assessment
- All radiographs will be taken with a localising device to control for angulation and magnification.
- Calibrated measurement tools in the dental practice management software will be used to measure the diameter of the lesion across the longest diameter.
Statistical and Analytical Plans
- General Considerations Intention-to-treat population is considered the main analysis population. The intention-to-treat population includes all subjects who were assigned a randomization number. Study subject's demographic and pre-operative characteristics will be summarized for each treatment group.
- Conditions
- Root Canal Obturation
- Being tested
- TotalFill® Bioceramic sealer, AH plus® sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TotalFill® Bioceramic sealerDevice
The participant will be treated with TotalFill® Bioceramic sealer.
AH plus® sealerDevice
The participant will be treated with AH plus® sealer.
| Study group | Role | What they receive |
|---|---|---|
| TotalFill® Bioceramic sealer | Experimental | 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. Receives: Device: TotalFill® Bioceramic sealer |
| AH plus® sealer | Active comparator | 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. Receives: Device: AH plus® sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the status of periapical lesion size
Proportion z-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).
Measured: comparison of the periapical lesion size at baseline, 6 month and 12 month
Secondary outcomes (1)
Comparison of the pain score of post-op pain
Proportion z-test will be carried out. The odds ratio with a 95% confidence interval will be reported. A two-sample t-test will be performed to access the change in pain score (Pain was recorded as "no pain" (score = 0) or a 5-point Likert scale ranging from very mild pain (score = 1) to severe pain (score = 5)) at post-op compared with pre-op between the two treatment groups. Shapiro Wilk's test and Levene's test will be performed to check the normality and homogenous variance assumption of the two-sample t-test. Non-parametric approach (Mann-Whitney U-test) will be employed if there is significant violations of the normality assumption.
Measured: Day 1, Day 3 and Day 7 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start13 Aug 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Root Canal ObturationStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- 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
- Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoria Yu, PhD, Principal investigator, National University Hosptial, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732170
- Sponsor's protocol ID
- 2018/00390
- Other IDs
- 2018
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2018
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Root Canal Treatment With TotalFill® Bioceramic Sealer and AH Plus® Sealer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03732170
- Acronym / sponsor ID
- 2018/00390
- Conditions
- Root Canal Obturation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 170 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Nov 2018 (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 study design is a double blinded randomized controlled trial and 170 subjects (teeth) , 85 in each of the 2 groups, will be enrolled from the patients at the NUH dental centre endodontic unit. The study aims to assess how the use of TotalFill® bioceramic sealer affects the healing outcome of apical periodontitis compared to a control AH plus®.
Conventional root canal treatment will be done during this study. Radiographs will be taken at each study visit during the study for root canal. The preoperative, postoperative and review clinical and radiographic data will be analysed.
Detailed description
Randomization and Blinding Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups. Allocation will be by random permuted block and stratified by gender to enhance balance. Computer generated randomized allocation for each subject will be concealed in opaque envelope. The envelope will only be opened by the operator on the obturation visit of the enrolled patient and the randomization number assigned to them.
In the event that a patient has more than 1 tooth eligible for the study, only one tooth on left and/or right side of the mouth will be recruited for the study. Therefore, a patient could contribute a maximum of two teeth for this study (i.e. a maximum of one tooth on each side of the mouth). Selection of tooth will be done using computer generated randomization number.
Study Visits and Procedures After cleaning and shaping and the patients are deemed ready for obturation, the patients will be randomly assigned to one of the 2 groups for obturation using AH plus® or TotalFill® bioceramic sealer.
- The patients and the examiners will be blinded to the type of sealer used but it would not be possible to blind the operators.
- Post Study Follow up and Procedures
- A follow up phone call will be made to collect the patient pain experience on day 1, day 3 and day 7 post treatment which they have recorded on their pain/discomfort diary.
- At the 6-month and 12-month review, patients will be examined for any clinical signs and symptoms and a review radiograph will be taken to assess the size of the periapical lesion.
- Radiographic assessment
- All radiographs will be taken with a localising device to control for angulation and magnification.
- Calibrated measurement tools in the dental practice management software will be used to measure the diameter of the lesion across the longest diameter.
Statistical and Analytical Plans
- General Considerations Intention-to-treat population is considered the main analysis population. The intention-to-treat population includes all subjects who were assigned a randomization number. Study subject's demographic and pre-operative characteristics will be summarized for each treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Study subject (tooth) will be randomized in a 1:1 allocation ratio between the two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| TotalFill® Bioceramic sealer | Experimental | Device: 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. |
| AH plus® sealer | Active comparator | Device: AH plus® 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. |
Who may qualify
- Ages
- 21 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A preoperative periapical radiograph will be required for diagnosis.
- Subjects at least 21 years old.
- Medically healthy
- In a patient with multiple teeth requiring root canal treatment, only 1 tooth from each side will be included and selected at random.
Key exclusion criteria (8 listed)
- Patient below 21 years old
- Pregnant women.
- Patients with autoimmune diseases and uncontrolled diabetes.
- Teeth with periodontal probing depths of 5mm or more.
- Incomplete root formation that is detected radiographically.
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 sealerThe participant will be treated with TotalFill® Bioceramic sealer. | Device | TotalFill® Bioceramic sealer |
| AH plus® sealerThe participant will be treated with AH plus® sealer. | Device | AH plus® sealer |
Primary outcome
Change in the status of periapical lesion size
Time frame: comparison of the periapical lesion size at baseline, 6 month and 12 month
Proportion z-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).
1 secondary outcome
Comparison of the pain score of post-op pain
Time frame: Day 1, Day 3 and Day 7 post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes
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.
Victoria Yu, PhD principal investigator
National University Hosptial, Singapore
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 plus® sealer in people with Root Canal Obturation, run by National University Hospital, Singapore at 1 site in Singapore.
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 4 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in the status of periapical lesion size (time frame: comparison of the periapical lesion size at baseline, 6 month and 12 month). 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 20 Nov 2025.