Post Operative Pain, AcutePhase 2/3NCT07266974
To Evaluate Post Operative Pain Using Two Different Kind of Sealers in Obturation of Teeth With Symptomatic Irreversible Pulpitis During Second Visit When the Patient is Painless
A Phase 2/3 study testing AH-Plus Epoxy Resin Sealer and bioceramic sealer in people with Post Operative Pain, Acute and Irreversible Pulpitis, run by Jaweria Gul Keyani at 1 site in Pakistan.
Trial summary
The goal of this randomized clinical trial is to evaluate pain after root canal treatment using two different kinds of sealers during obturation in 60 healthy , male and female patients ages between 18 to 40 years. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Post Operative Pain, Acute, Irreversible Pulpitis
- What is being tested?
- AH-Plus Epoxy Resin Sealer and bioceramic sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2026to 1 Oct 2026
- Phase
- Phase 2/3
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients ranging from 18 to 40 years.
- Patients whose teeth have been diagnosed with Symptomatic irreversible pulpitis.
- maxillary and mandibular teeth.
- A normal periapical condition on radiograph, or one with little to no periodontal ligament (PDL) space widening, confirming the normal periapical state.
- Teeth that can be restored.
- Teeth with healthy periodontium.
Who cannot join
- Non-restorable teeth.
- Patients with poor health whose systemic complications could change the course of treatment.
- Teeth with immature roots.
- Teeth with periapical lesions or apical periodontitis.
- Teeth with Necrotic pulp.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr lubna Pasha contact
Pakistan1 site
Margalla Institute of Health Sciences, Gulraiz phase III Quaid e azam Avenue, Rawalpindi
Rawalpindi, Punjab Province, 46000
About this study
Official title: Evaluation of Post -Operative Pain After Obturation Using Two Different Types of Sealers - A Randomized Clinical Trial
The goal of this randomized clinical trial is to evaluate pain after root canal treatment using two different kinds of sealers during obturation in 60 healthy , male and female patients ages between 18 to 40 years. The main aims is to systematically evaluate and compare post-operative pain levels in patients undergoing root canal treatment with two different types of endodontic sealers: AH plus (SEAL APEX) and bio ceramic sealer(META)
- By identifying the sealer that leads to the least discomfort, this research could significantly enhance patient care, minimize recovery time, and improve overall treatment success in endodontics.
Participants in both groups will be given a visual analogue scale(VAS) to measure the pain level after the root canal treatment has been completed. They will measure pain levels at 12, 24 and 48 hours. All information will be recorded on proforma and compared.
Read the detailed description
•This randomized clinical trial is done to evaluate and compare post operative pain after obturation using two different sealers .A total of 60 participants will be selected using a non-probability consecutive sampling method. After enrollment, participants will be randomly allocated into two equal groups (30 each),Group A and Group B using the lottery method. Group A patients will be given AH plus sealer and Group B will be given bio-ceramic sealer. Root canal treatment will be performed in two visits using local anesthesia under rubber dam isolation. • After drying with paper points , in group 1 an even ratio of 1:1 from the base and catalyst of the AH plus will be manually mixed on a paper pad with a spatula and introduced into the canal on the master cone.
- In group B, sealer will be introduced with the bio ceramic sealer tube and cold lateral compaction technique will be used for obturation in both of the groups . Composite will be used for restoration.
- The patients will be called again for evaluation of pain and its severity at, 24hrs, 48hrs and 72hrs. Effectiveness of sealers will be measured as no, mild, moderate or severe pain on visual analogue scale (VAS). All procedures will be done under the supervision of supervisor. All this information will be recorded on proforma.
- Patients shall be prescribed ibuprofen 400mg post-operatively shall be prescribed. Patients will be given VAS scale so they can record their pain at home before taking the analgesic.
- Data will be entered and analyzed in IMB SPSS version 26. Mean and Standard deviation (SD) of VAS scores at each time point (12h, 24h, 48h) for both types of sealers shall be calculated. Independent t-test to compare the VAS scores between two groups (Sealer 1 vs. Sealer 2).
- Significance level to set at p value <0.05 this study will further add to the literature regarding the efficacy of sealer in reducing post operative pain and assessing which sealer is better and effective to use for clinicians.
- Conditions
- Post Operative Pain, Acute, Irreversible Pulpitis
- Being tested
- AH-Plus Epoxy Resin Sealer, bioceramic sealer
- Keywords
- post operative pain, bioceramic sealer, irreversible pulpitis
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AH-Plus Epoxy Resin SealerDrug
AH plus sealer is an epoxy resin based sealer that is biocompatible with good sealing ability
bioceramic sealerDrug
MTA based sealers,biocermic sealers are biocompatible, safe to use
| Study group | Role | What they receive |
|---|---|---|
| Group A , AH plus sealer , Group B ( bioceramic sealer) | Active comparator | patients in group A will recieve AH plus sealer and in group B shall recieve bioceramic sealer for obturation during root canal treatment Receives: Drug: bioceramic sealer |
| Group A , (AH plus sealer ) , Group B ( bioceramic sealer) | Active comparator | patients in Group A will recieve Ah plus sealer for obturation and patients in group B shall recieve bioceramic sealer for obtration during root canal treatment second visit Receives: Drug: AH-Plus Epoxy Resin Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
post operative pain in both sealer groups after obturation
Post-operative pain levels will be measured and compared in both groups using Visual Analogue Scale (VAS) Patients were asked to rate their pain on a numerical scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst pain imaginable.
For interpretation, pain intensity was categorized as follows:
1-3: Mild pain
4-6: Moderate pain
7-10: Severe pain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaweria Gul Keyani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaweria Gul Keyani, Margalla Institute of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266974
- Sponsor's protocol ID
- DJ/277/25
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post -Operative Pain After Obturation Using Two Different Types of Sealers - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07266974
- Acronym / sponsor ID
- DJ/277/25
- Conditions
- Post Operative Pain, Acute, Irreversible Pulpitis
- Keywords
- post operative pain, bioceramic sealer, irreversible pulpitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jaweria Gul KeyaniUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Dec 2025 (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 goal of this randomized clinical trial is to evaluate pain after root canal treatment using two different kinds of sealers during obturation in 60 healthy , male and female patients ages between 18 to 40 years. The main aims is to systematically evaluate and compare post-operative pain levels in patients undergoing root canal treatment with two different types of endodontic sealers: AH plus (SEAL APEX) and bio ceramic sealer(META)
- By identifying the sealer that leads to the least discomfort, this research could significantly enhance patient care, minimize recovery time, and improve overall treatment success in endodontics.
Participants in both groups will be given a visual analogue scale(VAS) to measure the pain level after the root canal treatment has been completed. They will measure pain levels at 12, 24 and 48 hours. All information will be recorded on proforma and compared.
Detailed description
•This randomized clinical trial is done to evaluate and compare post operative pain after obturation using two different sealers .A total of 60 participants will be selected using a non-probability consecutive sampling method. After enrollment, participants will be randomly allocated into two equal groups (30 each),Group A and Group B using the lottery method. Group A patients will be given AH plus sealer and Group B will be given bio-ceramic sealer. Root canal treatment will be performed in two visits using local anesthesia under rubber dam isolation. • After drying with paper points , in group 1 an even ratio of 1:1 from the base and catalyst of the AH plus will be manually mixed on a paper pad with a spatula and introduced into the canal on the master cone.
- In group B, sealer will be introduced with the bio ceramic sealer tube and cold lateral compaction technique will be used for obturation in both of the groups . Composite will be used for restoration.
- The patients will be called again for evaluation of pain and its severity at, 24hrs, 48hrs and 72hrs. Effectiveness of sealers will be measured as no, mild, moderate or severe pain on visual analogue scale (VAS). All procedures will be done under the supervision of supervisor. All this information will be recorded on proforma.
- Patients shall be prescribed ibuprofen 400mg post-operatively shall be prescribed. Patients will be given VAS scale so they can record their pain at home before taking the analgesic.
- Data will be entered and analyzed in IMB SPSS version 26. Mean and Standard deviation (SD) of VAS scores at each time point (12h, 24h, 48h) for both types of sealers shall be calculated. Independent t-test to compare the VAS scores between two groups (Sealer 1 vs. Sealer 2).
- Significance level to set at p value <0.05 this study will further add to the literature regarding the efficacy of sealer in reducing post operative pain and assessing which sealer is better and effective to use for clinicians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A , AH plus sealer , Group B ( bioceramic sealer) | Active comparator | Drug: bioceramic sealerpatients in group A will recieve AH plus sealer and in group B shall recieve bioceramic sealer for obturation during root canal treatment |
| Group A , (AH plus sealer ) , Group B ( bioceramic sealer) | Active comparator | Drug: AH-Plus Epoxy Resin Sealerpatients in Group A will recieve Ah plus sealer for obturation and patients in group B shall recieve bioceramic sealer for obtration during root canal treatment second visit |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Patients ranging from 18 to 40 years.
Key exclusion criteria (5 listed)
- Non-restorable teeth.
- Patients with poor health whose systemic complications could change the course of treatment.
- Teeth with immature roots.
- Teeth with periapical lesions or apical periodontitis.
- Teeth with Necrotic pulp.
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 |
|---|---|---|
| AH-Plus Epoxy Resin SealerAH plus sealer is an epoxy resin based sealer that is biocompatible with good sealing ability | Drug | Group A , (AH plus sealer ) , Group B ( bioceramic sealer) |
| bioceramic sealerMTA based sealers,biocermic sealers are biocompatible, safe to use | Drug | Group A , AH plus sealer , Group B ( bioceramic sealer) |
Primary outcome
post operative pain in both sealer groups after obturation
Time frame: 6 months
Post-operative pain levels will be measured and compared in both groups using Visual Analogue Scale (VAS) Patients were asked to rate their pain on a numerical scale from 0 to 10, where 0 indicated no pain and 10 indicated the worst pain imaginable. For interpretation, pain intensity was categorized as follows: 1-3: Mild pain 4-6: Moderate pain 7-10: Severe pain
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 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Dr lubna Pasha contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing AH-Plus Epoxy Resin Sealer and bioceramic sealer in people with Post Operative Pain, Acute and Irreversible Pulpitis, run by Jaweria Gul Keyani 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 5 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 Jan 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jaweria gul keyani (+ 92 3312931111, jaweriagulkeyani@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post operative pain in both sealer groups after obturation (time frame: 6 months). 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 Jan 2026.