PainNCT07388368
Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate vs Resin-Based Sealers
A study testing Tricalcium silicate sealar and Resin based sealer in people with Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain
- What is being tested?
- Tricalcium silicate sealar and Resin based sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 30 Jan 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients of age group 18 to 60 years
- Healthy patients with ASA class 1 and 2
- Patients of both genders
- Teeth diagnosed as symptomatic irreversible pulpitis
- Single as well as multirooted teeth
Who cannot join
- Teeth with calcified or previously treated canals
- Immunocompromised or mentally handicapped patients
- Pregnant or lactating mothers
- Teeth with periodontal probing depths of 5 mm or more
- Cracked or un restorable teeth
- Teeth where root canal instrumentation could not reach within 2 mm of the radiographic apex
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Armed Force Institute of Dentistry
Rawalpindi, Punjab Province, 46000
Pooja Kumari, 03133422793, dhomejapooja@gmail.com
About this study
Official title: A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis
This is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Read the detailed description
- The study will be conducted after approval from the Institutional Ethics Review Committee of the Armed Forces Institute of Dentistry. Informed written consent will be obtained from all patients, and demographic details (name, age, gender, and contact information) will be collected. This is a randomized clinical trial, and the sample size will be divided into two groups using computer-generated randomization. Group 1 will receive Endoplus (resin-based sealer), and Group 2 will receive CeraSeal (bioceramic sealer).
All root canal procedures will be performed by the principal investigator. At the first visit, local anesthesia (2% lignocaine with 1:100,000 epinephrine) and rubber dam isolation will be used. Working length will be determined using an apex locator and confirmed with a periapical radiograph. Chemo-mechanical preparation will be performed using 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA). Cleaning and shaping will be done up to F2 ProTaper using hand files and nickel-titanium (NiTi) rotary files, with recapitulation between each file to maintain canal patency. Non-setting calcium hydroxide will be placed as an intracanal medicament, followed by a temporary restoration with Cavit. Patients will be recalled after one week for obturation and will proceed only if asymptomatic.
At the second visit, obturation will be carried out according to group allocation. Group 1 will receive Endoplus resin-based sealer using a single-cone gutta-percha technique with a heated plugger (System B). Group 2 will receive CeraSeal bioceramic sealer with matched bioceramic cones using the same System B technique. Accessory cones will be used for wide or irregular canals. A permanent composite restoration (Coltene) will be placed, and occlusion will be adjusted.
Postoperative pain will be recorded using a Visual Analogue Scale (VAS) at 24 hours, 72 hours, and 7 days. Ibuprofen will be prescribed only if the pain becomes unbearable, and patients will document the dose and frequency taken. Two independent blinded endodontists will evaluate radiographs for technical errors or sealer extrusion. The primary measure of success will be the level of postoperative pain at follow-up, comparing outcomes between Endoplus resin-based sealer and CeraSeal bioceramic sealer.
- Conditions
- Pain
- Being tested
- Tricalcium silicate sealar, Resin based sealer
- Keywords
- root canal sealar, postobturation pain, bioceramic sealer, resin based sealar
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tricalcium silicate sealarDrug
Also called CeraSeal sealer, bioceramic sealer, calcium silicate sealer
Ceraseal (bioceramic sealer) - assigned to Group 2
Resin based sealerDrug
Also called Endoplus sealer, resin sealer, gutta-percha sealer
Endoplus (resin-based sealer) - assigned to Group 1
| Study group | Role | What they receive |
|---|---|---|
| Tricalcium silicate based sealer (Bio ceramic) | Active comparator | CeraSeal bioceramic sealer will be used for obturation with matched bioceramic cones and a heated plugger (System B). Receives: Drug: Tricalcium silicate sealar |
| Resin based sealer | Experimental | Endoplus resin-based sealer will be used for obturation with single-cone gutta-percha and a heated plugger (System B) Receives: Drug: Resin based sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)
Postoperative pain will be recorded using a 10-centimeter Visual Analogue Scale (VAS). On this scale, 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to greater pain intensity, meaning more pain. Patients will self-report their pain level at each time point (24 hours, 72 hours, and 7 days). This measure will be used to compare postoperative pain between patients treated with Endoplus resin-based sealer and CeraSeal bioceramic sealer.
Measured: 24 hours, 72 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Jul 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- A comparative evaluation of postobturation pain after root canal treatment using tricalcium silicate versus resin-based sealers in cases with symptomatic irreversible pulpitis
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pooja Kumari, Armed Forces Institute of Dentistry, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388368
- Sponsor's protocol ID
- Protocol-001
- Status last verified
- Jul 2026
- First submitted
- 7 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared with other researchers because this trial involves a small patient sample, and the data contains identifiable clinical information that cannot be fully anonymized without compromising patient confidentiality. The dataset is intended solely for analysis within the approved research protocol, as permitted by the Institutional Ethics Review Committee. Therefore, IPD sharing is not planned.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT07388368
- Acronym / sponsor ID
- Protocol-001
- Conditions
- Pain
- Keywords
- root canal sealar, postobturation pain, bioceramic sealer, resin based sealar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 5 Feb 2026 (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 is a randomized controlled trial comparing the mean and standard deviation of postobturation pain using two different sealers: a tricalcium silicate-based sealer (CeraSeal) and a resin-based sealer (Endoplus) in patients with symptomatic irreversible pulpitis undergoing root canal treatment.
Detailed description
- The study will be conducted after approval from the Institutional Ethics Review Committee of the Armed Forces Institute of Dentistry. Informed written consent will be obtained from all patients, and demographic details (name, age, gender, and contact information) will be collected. This is a randomized clinical trial, and the sample size will be divided into two groups using computer-generated randomization. Group 1 will receive Endoplus (resin-based sealer), and Group 2 will receive CeraSeal (bioceramic sealer).
All root canal procedures will be performed by the principal investigator. At the first visit, local anesthesia (2% lignocaine with 1:100,000 epinephrine) and rubber dam isolation will be used. Working length will be determined using an apex locator and confirmed with a periapical radiograph. Chemo-mechanical preparation will be performed using 2.5% sodium hypochlorite (NaOCl) and 17% ethylenediaminetetraacetic acid (EDTA). Cleaning and shaping will be done up to F2 ProTaper using hand files and nickel-titanium (NiTi) rotary files, with recapitulation between each file to maintain canal patency. Non-setting calcium hydroxide will be placed as an intracanal medicament, followed by a temporary restoration with Cavit. Patients will be recalled after one week for obturation and will proceed only if asymptomatic.
At the second visit, obturation will be carried out according to group allocation. Group 1 will receive Endoplus resin-based sealer using a single-cone gutta-percha technique with a heated plugger (System B). Group 2 will receive CeraSeal bioceramic sealer with matched bioceramic cones using the same System B technique. Accessory cones will be used for wide or irregular canals. A permanent composite restoration (Coltene) will be placed, and occlusion will be adjusted.
Postoperative pain will be recorded using a Visual Analogue Scale (VAS) at 24 hours, 72 hours, and 7 days. Ibuprofen will be prescribed only if the pain becomes unbearable, and patients will document the dose and frequency taken. Two independent blinded endodontists will evaluate radiographs for technical errors or sealer extrusion. The primary measure of success will be the level of postoperative pain at follow-up, comparing outcomes between Endoplus resin-based sealer and CeraSeal bioceramic sealer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A comparative evaluation of postobturation pain after root canal treatment using tricalcium silicate versus resin-based sealers in cases with symptomatic irreversible pulpitis
| Arm | Type | Receives |
|---|---|---|
| Tricalcium silicate based sealer (Bio ceramic) | Active comparator | Drug: Tricalcium silicate sealarCeraSeal bioceramic sealer will be used for obturation with matched bioceramic cones and a heated plugger (System B). |
| Resin based sealer | Experimental | Drug: Resin based sealerEndoplus resin-based sealer will be used for obturation with single-cone gutta-percha and a heated plugger (System B) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Patients of age group 18 to 60 years
Key exclusion criteria (6 listed)
- Teeth with calcified or previously treated canals
- Immunocompromised or mentally handicapped patients
- Pregnant or lactating mothers
- Teeth with periodontal probing depths of 5 mm or more
- Cracked or un restorable 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 |
|---|---|---|
| Tricalcium silicate sealarAlso: CeraSeal sealer, bioceramic sealer, calcium silicate sealerCeraseal (bioceramic sealer) - assigned to Group 2 | Drug | Tricalcium silicate based sealer (Bio ceramic) |
| Resin based sealerAlso: Endoplus sealer, resin sealer, gutta-percha sealerEndoplus (resin-based sealer) - assigned to Group 1 | Drug | Resin based sealer |
Primary outcome
Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS)
Time frame: 24 hours, 72 hours and 7 days
Postoperative pain will be recorded using a 10-centimeter Visual Analogue Scale (VAS). On this scale, 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores correspond to greater pain intensity, meaning more pain. Patients will self-report their pain level at each time point (24 hours, 72 hours, and 7 days). This measure will be used to compare postoperative pain between patients treated with Endoplus resin-based sealer and CeraSeal bioceramic sealer.
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 29 Jul 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared with other researchers because this trial involves a small patient sample, and the data contains identifiable clinical information that cannot be fully anonymized without compromising patient confidentiality. The dataset is intended solely for analysis within the approved research protocol, as permitted by the Institutional Ethics Review Committee. Therefore, IPD sharing is not planned.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tricalcium silicate sealar and Resin based sealer in people with Pain, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 29 Jul 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 Pakistan. 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?
Contact Pooja Kumari (03133422793, dhomejapooja@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain after root canal treatment assessed using a Visual Analogue Scale (VAS) (time frame: 24 hours, 72 hours and 7 days). 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 29 Jul 2026.