Post Operative PainNCT07253025
Comparison of Post Operative Pain in Resin-Based and Bioceramic Based Root Canal Sealers in Patient Presenting at Peshawar Dental College.
A study testing Resin based root canal sealer and Bioceramic based root canal sealer in people with Post Operative Pain, run by Prime Foundation at 1 site in Pakistan.
Trial summary
The goal of this clinical trial is to compare the post operative pain in Resin-Based and Bio ceramic based sealers in patients presenting at Peshawar dental college. Root canal sealer is a material use to avoid gaps between the filling material and root canal Walls, if it is extended beyond canals can cause mild… Read more about this study
- Who is it for?
- Ages 17 to 70 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Resin based root canal sealer and Bioceramic based root canal sealer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Nov 2025to 2 Apr 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 17 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Gender Both males and females
- Age Group (18-70) Years
- Patients with Mandibular or Maxillary single-rooted teeth identified with symptomatic irreversible pulpitis either with symptomatic apical periodontitis or normal apical tissues
Who cannot join
- Patients with immature apices
- Patients with root resorption
- Patients medically compromised, Patients on medications i.e analgesic or anti-inflammatory drugs,
- pregnant/lactating females
- Patient came with flare up pain
- Patients who refused to participate in this study.
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
Peshawar Dental Collge
Peshawar, Khyber Pakhtoon Khawa(KPK)a, 25000
Dr. Shah Zaman, BDS, 0922 3159393980, zshah5778@gmail.com
Dr. Iftikhar Akbar, BDS, FCPS
About this study
Official title: Comparison of Post Operative Pain in Resin-Based and Bio Ceramic Based Root Canal Sealer in Patient Presenting at Peshawar Dental College
The goal of this clinical trial is to compare the post operative pain in Resin-Based and Bio ceramic based sealers in patients presenting at Peshawar dental college.
Root canal sealer is a material use to avoid gaps between the filling material and root canal Walls, if it is extended beyond canals can cause mild inflammation and post operative pain Hypothesis: There is difference in post operative pain in Resin based and Bio ceramic based sealers in patients presenting at Peshawar dental college.
Read more
.Post operative pain:: It will be defined on the basis of Visual Analog Score (VAS) after 24 hours and 48hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates the severe pain. Presence of pain will be validated, if Pain > 3 on VAS.
•The calculated sample size is 180 (90 in each group) Patients will be briefed with information related to the goals, risks, and benefits of the study, and written informed consent form will be taken from all participating patients. To make sure the inclusion criteria are strictly enforced, medical history will be taken. Demographic information like to age, gender, and address will be recorded on a designated proforma. Maxillary or mandibular single-rooted teeth confirmed with symptomatic irreversible pulpitis i.e. normal apical tissues/symptomatic apical periodontitis will be included. Patients will be randomly divided into two groups Resin-based sealer (AH Plus)-Group A (90) and mineral trioxide aggregate (MTA) fillapex-Group B (90) by lottery method. Before treatment the patients will be educated that how to complete a visual analogue scale (VAS) to evaluate their pain score. The VAS included a 10 cm straight horizontal line numbered at each centimetre with the following criteria. Local anaesthetic with 2% lignocaine containing 1:80000 epinephrine will be administered to each patient. A rubber dam will be applied. The endodontic access cavities will be formed with endo access burs. Working length will be established with #10 K file and the root canal will be instrumented with one shape rotary system up to #25.6% under copious irrigation with 3% sodium hypochlorite. Before obturation root canals will be final rinse with 5 ml of 17% EDTA solution. In both treatment groups, the root canal will be dried with paper points and obdurate with cold lateral compaction technique with the help of gutta-percha cones and AH plus /MTA fillapex. Coronal access cavities will be restored with direct composite restorations with the help of dentinal adhesives and universal composite resin. The continuous-wave approach will be used in the AH Plus group, and the single-cone approach will be used in the MTA fillapex. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.
- Conditions
- Post Operative Pain
- Being tested
- Resin based root canal sealer, Bioceramic based root canal 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.
Resin based root canal sealerOther
Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.
The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria It will be defined on the basis of Visual Analog Score (VAS) after 24 hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates the severe pain. Presence of pain will be validated, if Pain > 3 on VAS.
Bioceramic based root canal sealerOther
Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.
The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria It will be defined on the basis of Visual Analog Score (VAS) after 24 hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates
| Study group | Role | What they receive |
|---|---|---|
| POST OPERATIVE PAIN IN RESIN-BASED ROOT CANAL SEALERS | Other | Patients will be randomly divided into two groups .one group will recived Resin-based sealer (AH Plus)-Group A (90) . Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Receives: Other: Resin based root canal sealer |
| POST OPERATIVE PAIN BIOCERAMIC BASED ROOT CANAL SEALERS | Other | Patients will be randomly divided into two groups. Mineral trioxide aggregate (MTA) fillapex-Group B (90). Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Receives: Other: Bioceramic based root canal sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the baseline of pain, as measure by the visual analog scale ( VAS)
Scores are measure on 10 numbers on VAS , where 0 Indicate no pain and 10 Indicate severe pain , presence of pain will be validated, if pain score >3 on VAS scale,
Measured: 24 hours , 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start30 Nov 2025 (estimated)
- Primary completion2 Apr 2026 (estimated)
- Study completion2 Apr 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 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prime Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shah Zaman, Prime Foundation
- Investigators
- Dr. Shah Zaman, BDS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253025
- Sponsor's protocol ID
- Prime Foundation Pakistan
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol, inform consent, study results
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Operative Pain in Resin-Based and Bio Ceramic Based Root Canal Sealer in Patient Presenting at Peshawar Dental College
- ClinicalTrials.gov ID
- NCT07253025
- Acronym / sponsor ID
- Prime Foundation Pakistan
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Prime FoundationUniversity, hospital or other
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 2 Apr 2026 (estimated)
- First posted
- 28 Nov 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 clinical trial is to compare the post operative pain in Resin-Based and Bio ceramic based sealers in patients presenting at Peshawar dental college.
Root canal sealer is a material use to avoid gaps between the filling material and root canal Walls, if it is extended beyond canals can cause mild inflammation and post operative pain Hypothesis: There is difference in post operative pain in Resin based and Bio ceramic based sealers in patients presenting at Peshawar dental college.
.Post operative pain:: It will be defined on the basis of Visual Analog Score (VAS) after 24 hours and 48hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates the severe pain. Presence of pain will be validated, if Pain > 3 on VAS.
•The calculated sample size is 180 (90 in each group) Patients will be briefed with information related to the goals, risks, and benefits of the study, and written informed consent form will be taken from all participating patients. To make sure the inclusion criteria are strictly enforced, medical history will be taken. Demographic information like to age, gender, and address will be recorded on a designated proforma. Maxillary or mandibular single-rooted teeth confirmed with symptomatic irreversible pulpitis i.e. normal apical tissues/symptomatic apical periodontitis will be included. Patients will be randomly divided into two groups Resin-based sealer (AH Plus)-Group A (90) and mineral trioxide aggregate (MTA) fillapex-Group B (90) by lottery method. Before treatment the patients will be educated that how to complete a visual analogue scale (VAS) to evaluate their pain score. The VAS included a 10 cm straight horizontal line numbered at each centimetre with the following criteria. Local anaesthetic with 2% lignocaine containing 1:80000 epinephrine will be administered to each patient. A rubber dam will be applied. The endodontic access cavities will be formed with endo access burs. Working length will be established with #10 K file and the root canal will be instrumented with one shape rotary system up to #25.6% under copious irrigation with 3% sodium hypochlorite. Before obturation root canals will be final rinse with 5 ml of 17% EDTA solution. In both treatment groups, the root canal will be dried with paper points and obdurate with cold lateral compaction technique with the help of gutta-percha cones and AH plus /MTA fillapex. Coronal access cavities will be restored with direct composite restorations with the help of dentinal adhesives and universal composite resin. The continuous-wave approach will be used in the AH Plus group, and the single-cone approach will be used in the MTA fillapex. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POST OPERATIVE PAIN IN RESIN-BASED ROOT CANAL SEALERS | Other | Other: Resin based root canal sealerPatients will be randomly divided into two groups .one group will recived Resin-based sealer (AH Plus)-Group A (90) . Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. |
| POST OPERATIVE PAIN BIOCERAMIC BASED ROOT CANAL SEALERS | Other | Other: Bioceramic based root canal sealerPatients will be randomly divided into two groups. Mineral trioxide aggregate (MTA) fillapex-Group B (90). Before treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. |
Who may qualify
- Ages
- 17 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Gender Both males and females
- Age Group (18-70) Years
- Patients with Mandibular or Maxillary single-rooted teeth identified with symptomatic irreversible pulpitis either with symptomatic apical periodontitis or normal apical tissues
Key exclusion criteria (6 listed)
- Patients with immature apices
- Patients with root resorption
- Patients medically compromised, Patients on medications i.e analgesic or anti-inflammatory drugs,
- pregnant/lactating females
- Patient came with flare up pain
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 |
|---|---|---|
| Resin based root canal sealerBefore treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma. The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria It will be defined on the basis of Visual Analog Score (VAS) after 24 hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates the severe pain. Presence of pain will be validated, if Pain > 3 on VAS. | Other | POST OPERATIVE PAIN IN RESIN-BASED ROOT CANAL SEALERS |
| Bioceramic based root canal sealerBefore treatment the patients will be educated that how to complete a visual analog scale (VAS) to evaluate their pain score. Postoperative VAS scores will be recorded after the 24 hours and 48 hours of the treatment for the determination of post-operative pain. All assessment will be recorded on a pre-designed proforma. The VAS included a 10 cm straight horizontal line numbered at each centimeter with the following criteria It will be defined on the basis of Visual Analog Score (VAS) after 24 hours in both treatment groups. VAS includes 0-10 numbers, where 0 indicates no pain, and 10 indicates | Other | POST OPERATIVE PAIN BIOCERAMIC BASED ROOT CANAL SEALERS |
Primary outcome
Change in the baseline of pain, as measure by the visual analog scale ( VAS)
Time frame: 24 hours , 48 hours
Scores are measure on 10 numbers on VAS , where 0 Indicate no pain and 10 Indicate severe pain , presence of pain will be validated, if pain score >3 on VAS scale,
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 28 Nov 2025.
- Parent study ReferenceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol, inform consent, study results
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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. Shah Zaman, BDS principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resin based root canal sealer and Bioceramic based root canal sealer in people with Post Operative Pain, run by Prime Foundation 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 3 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 28 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 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 Dr. Shah Zaman, BDS (0092 3159393980, zshah5778@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the baseline of pain, as measure by the visual analog scale ( VAS) (time frame: 24 hours , 48 hours). 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 28 Nov 2025.