Calcium Silicate Based Sealer (CSBS)CBSSNCT07865429
Efficiency of Calcium Hydroxide and Calcium Silicate-Based Sealers in Maxillary and Mandibular Molars on Post-Root Canal Pain
A study testing Calcium silicate based sealer in people with Calcium Silicate Based Sealer (CSBS), run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
patients reported at department of Operative dentistry diagnosis section , patients coming to operative department of DIDC-DUHS with the chief complain of moderate to severe pain will be assessed .Complete history of each patient will be obtained along with clinical examination including percussion test, presence of… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Calcium Silicate Based Sealer (CSBS)
- What is being tested?
- Calcium silicate based sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2026to 1 Jun 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Medically healthy patients
- Age: 18 to 45 years
- Vital Pulp with moderate to severe pre-operative pain score (VAS score 4-10 on EPT).
- Symptomatic apical periodontitis
- Mandibular and maxillary molars.
- Periapical index (PAI) scores 1-2.
Who cannot join
- Patients experiencing root resorption
- Teeth with incomplete root development
- Calcified canals
- Severe malocclusion
- Pregnant or breastfeeding patients
- Patients who have used analgesics or anti-inflammatory medications within the past 24 hours
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
Dr Ayesha Tariq
Karachi, 75100
Ayesha Tariq, Postgraduate Trainee- FCPS, 03361265165, ayesha.tariq157@gmail.com
Dr Farah Naz, HOD of Operative and Endodonti
About this study
Official title: Effectiveness of Calcium Silicate- and Calcium Hydroxide-Based Sealers on Post-Endodontic Pain
patients reported at department of Operative dentistry diagnosis section , patients coming to operative department of DIDC-DUHS with the chief complain of moderate to severe pain will be assessed .Complete history of each patient will be obtained along with clinical examination including percussion test, presence of swelling, sinus tract and mobility of tooth. Pulp sensitivity will be assessef. Periapical x-ray will be used to evaluate periapical status PAI score. . Following anesthesia, the tooth will be isolated with a rubber dam to maintain a dry operating field. An access cavity will then be prepared. The presence of bleeding within the pulp chamber will be regarded as an indicator of pulp vitality. The (WL) will be established using patency files . An endodontic motor (eight teeth E-connect) will be programmed for root canal instrumentation. Root canals will be irrigated with sodium hypochlorite (NaOCl). Root canals will be dried using paper points, and will take master cone periapical radiograph before final obturation procedure. For the CSBS group (CERASEAL; Meta Biomed Co., Cheongju, Korea), the sealer will be applied and a single cone will be used for obturation. For the CHBS group (Seal apex), the obturation will be completed via cold lateral condensation. The teeth will be restored with composite (LUNA SDI). Single operator will perform the complete procedure. Analgesic ibuprofen 400 mg (Brufen) will be prescribed to the patient in case of severe pain
- Conditions
- Calcium Silicate Based Sealer (CSBS)
- Being tested
- Calcium silicate based sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium silicate based sealerOther
Root canal sealer used in ENDODONTIC treatment with core material for obturation of root canals
| Study group | Role | What they receive |
|---|---|---|
| Experimental :Calcium silicate based sealer | Experimental | Root canal sealer (CSBS) Receives: Other: Calcium silicate based sealer |
| Calcium hydroxide based sealer | Experimental | Root canal sealer (CHBS) Receives: Other: Calcium silicate based sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured using a Visual Analog Scale (VAS)
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will record their pain intensity at 6, 24, and 48 hours and at 3 and 7 days after root canal treatment. VAS pain scores at each time point will be recorded and compared between the calcium silicate-based sealer and calcium hydroxide-based sealer groups.
Measured: 6,24 and 48 hours and after 3 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 posted8 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcium Silicate Based Sealer (CSBS)Studies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Tariq, Dow University of Health Sciences
- Investigators
- Dr Ayesha Naz Tariq, Postgraduate Trainee- FCPS, Principal investigator, Dow University of Health SciencesDr Ayesha Tariq, Postgraduate Trainee- FCPS, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865429
- Sponsor's protocol ID
- IRB-4095/DUHS/approval/2025/
- Acronym
- CBSS
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPS will not be shared outside the study team to ensure patient confidentiality and privacy. Data will be used only for the purposes of this study and will remain restricted to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Calcium Silicate- and Calcium Hydroxide-Based Sealers on Post-Endodontic Pain
- ClinicalTrials.gov ID
- NCT07865429
- Acronym / sponsor ID
- CBSS / IRB-4095/DUHS/approval/2025/
- Conditions
- Calcium Silicate Based Sealer (CSBS)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Oct 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.
patients reported at department of Operative dentistry diagnosis section , patients coming to operative department of DIDC-DUHS with the chief complain of moderate to severe pain will be assessed .Complete history of each patient will be obtained along with clinical examination including percussion test, presence of swelling, sinus tract and mobility of tooth. Pulp sensitivity will be assessef. Periapical x-ray will be used to evaluate periapical status PAI score. . Following anesthesia, the tooth will be isolated with a rubber dam to maintain a dry operating field. An access cavity will then be prepared. The presence of bleeding within the pulp chamber will be regarded as an indicator of pulp vitality. The (WL) will be established using patency files . An endodontic motor (eight teeth E-connect) will be programmed for root canal instrumentation. Root canals will be irrigated with sodium hypochlorite (NaOCl). Root canals will be dried using paper points, and will take master cone periapical radiograph before final obturation procedure. For the CSBS group (CERASEAL; Meta Biomed Co., Cheongju, Korea), the sealer will be applied and a single cone will be used for obturation. For the CHBS group (Seal apex), the obturation will be completed via cold lateral condensation. The teeth will be restored with composite (LUNA SDI). Single operator will perform the complete procedure. Analgesic ibuprofen 400 mg (Brufen) will be prescribed to the patient in case of severe pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental :Calcium silicate based sealer | Experimental | Other: Calcium silicate based sealerRoot canal sealer (CSBS) |
| Calcium hydroxide based sealer | Experimental | Other: Calcium silicate based sealerRoot canal sealer (CHBS) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Medically healthy patients
- Age: 18 to 45 years
- Vital Pulp with moderate to severe pre-operative pain score (VAS score 4-10 on EPT).
- Symptomatic apical periodontitis
- Mandibular and maxillary molars.
Key exclusion criteria (6 listed)
- Patients experiencing root resorption
- Teeth with incomplete root development
- Calcified canals
- Severe malocclusion
- Pregnant or breastfeeding patients
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 |
|---|---|---|
| Calcium silicate based sealerRoot canal sealer used in ENDODONTIC treatment with core material for obturation of root canals | Other | Calcium hydroxide based sealer, Experimental :Calcium silicate based sealer |
Primary outcome
Postoperative pain intensity measured using a Visual Analog Scale (VAS)
Time frame: 6,24 and 48 hours and after 3 and 7 days
Postoperative pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will record their pain intensity at 6, 24, and 48 hours and at 3 and 7 days after root canal treatment. VAS pain scores at each time point will be recorded and compared between the calcium silicate-based sealer and calcium hydroxide-based sealer groups.
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 8 Oct 2026.
- Individual participant dataSharing planned: No. IPS will not be shared outside the study team to ensure patient confidentiality and privacy. Data will be used only for the purposes of this study and will remain restricted to the research team.
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.
Dr Ayesha Naz Tariq, Postgraduate Trainee- FCPS principal investigator
Dow University of Health Sciences
Dr Ayesha Tariq, Postgraduate Trainee- FCPS principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium silicate based sealer in people with Calcium Silicate Based Sealer (CSBS), run by Dow University of Health Sciences 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 6 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: opening soon, as of the sponsor's last update on 8 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 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 Ayesha Tariq, Recruiting (03350287343, ayesha.tariq157@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity measured using a Visual Analog Scale (VAS) (time frame: 6,24 and 48 hours and after 3 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 8 Oct 2026.