Post Endodontic PainNCT07767084
Influence of Sealer Composition on Post-Endodontic Pain
A study testing Calcium Hydroxide-based Sealer in people with Post Endodontic Pain, run by Minia University at 1 site in Egypt.
Trial summary
Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Post Endodontic Pain
- What is being tested?
- Calcium Hydroxide-based Sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2026to 14 Apr 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
- Patients requiring primary root canal treatment.
- Patients with acute irreversible pulpitis.
- Patients in good general health
Who cannot join
- Patients with systemic diseases affecting pain perception or healing.
- Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
- Pregnant or lactating women.
- Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Endodontics Department Faculty of Dentistry
Minya
Mohamed Abdel Mawla Mohamed Morsi, Lecturer, +201005757045, Dr.mohammed.abdelmawla@gmail.com
About this study
Official title: Influence of Sealer Composition on Post-Endodontic Pain: A Prospective Comparative Analysis of Three Root Canal Sealers
Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life.
The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.
Read the detailed description
Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life .
The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week . The pathophysiology of postoperative pain involves mechanical, chemical, or microbial injury to the periapical tissues, which triggers an acute inflammatory response characterized by the release of inflammatory mediators, vasodilation, increased vascular permeability, and leukocyte migration, ultimately activating sensory neurons and generating pain.
The etiology of PP is multifactorial, including patient-related factors such as age, gender, tooth type particularly mandibular molars preoperative pain, and periapical radiolucency, as well as treatment-related factors such as instrumentation protocol, irrigation solution, working length determination, occlusal adjustment, number of visits, anesthesia type, and prophylactic analgesics. Understanding these variables allows clinicians to select techniques and materials that minimize postoperative discomfort.
Root canal obturation plays a critical role in postoperative pain, as sealers may come into direct contact with periradicular tissues or extrude through the apical foramen, eliciting cytotoxic and inflammatory responses . The chemical composition and biocompatibility of the sealer influence tissue reaction, periapical healing, and subsequent pain perception.
Traditionally, epoxy resin-based sealers, such as AH Plus®, have been considered the gold standard due to their excellent sealing properties, radiopacity, dimensional stability, and clinical performance; however, extrusion of these sealers has been associated with cytotoxicity and inflammation.
Calcium hydroxide-based sealers have long been used in endodontics, providing antibacterial effects, low cytotoxicity, and osteogenic and cementogenic potential, contributing to periapical repair.
More recently, calcium silicate-based bioceramic sealers, including tricalcium silicate formulations like BioRoot and EndoSeal MTA, have gained popularity due to their bioactivity, biocompatibility, ability to set in humid conditions, alkaline pH, calcium ion release, antimicrobial properties, and promotion of tissue regeneration with lower inflammatory mediator production.
These properties suggest that bioceramic sealers may reduce postoperative pain compared to traditional sealers, while supporting enhanced periapical healing and osteogenic induction.
Despite studies evaluating postoperative pain with different sealers, results remain controversial, and there is limited evidence specifically comparing the effects of epoxy resin-based versus calcium silicate-based sealers on pain outcomes following single-visit endodontic treatment.
This highlights a need for further randomized clinical trials to assess the incidence and severity of postoperative pain associated with these materials, particularly in patients with varying pulpal and periapical conditions.
- Conditions
- Post Endodontic Pain
- Being tested
- Calcium Hydroxide-based Sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide-based SealerProcedure or surgery
Also called Bioceramic Sealer and Resin-based Sealer
to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Calcium Hydroxide-based Sealer: Sealapex): | Active comparator | About 22 cases will be subjected to:
1. Canals will be dried using sterile paper points, avoiding excessive desiccation to maintain optimal canal conditions prior to sealer placement.
2. The sealer will be dispensed according to the manufacturer's instructions. Gutta-percha master cones will be lightly coated with the sealer and inserted to the full working length. Additional sealer may be applied into the canal using a lentulo spiral or an appropriate intracanal delivery tip when indicated.
3. Accessory gutta-percha cones will be inserted into each canal to fill the spaces created by the spreader using a lateral compaction technique.
4. After achieving optimal obturation of the canal, excess gutta-percha will be seared off at the canal orifices using a heated instrument.
5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet moistened with saline. Receives: Procedure: Calcium Hydroxide-based Sealer |
| Group B (Bioceramic Sealer: Well-Root): | Active comparator | About 22 cases will be subjected to:
1. Canals will be dried using sterile paper points, avoiding over drying to maintain slight moisture within the dentinal tubules, which is favorable for the setting reaction of the bioceramic sealer.
2. The premixed bioceramic sealer will be dispensed directly into the canal using the manufacturer's intracanal delivery tip adjusted to 1-2 mm short of the working length, or applied onto the master gutta-percha cone prior to insertion.
3. The master gutta-percha cone will be inserted to the full working length. Accessory cones will be placed when necessary using a lateral compaction technique to ensure complete canal obturation.
4. After achieving optimal filling, excess gutta-percha will be seared off at the canal orifices using a heat carrier.
5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet lightly moistened with saline. Receives: Procedure: Calcium Hydroxide-based Sealer |
| Group C (Resin-based Sealer: ADSEAL): | Active comparator | About 22 cases will be subjected to:
1. Canals will be dried thoroughly using sterile paper points to ensure a moisture-free environment suitable for resin-based sealer application.
2. The resin-based sealer will be mixed according to the manufacturer's instructions and applied into the canal using a lentulo spiral or coated onto the master gutta-percha cone before insertion to the working length.
3. Accessory gutta-percha cones will be inserted using a lateral compaction technique to achieve dense canal obturation.
4. Excess gutta-percha will be removed at the canal orifices using a heated instrument after completion of obturation.
5. The pulp chamber will be cleaned from excess sealer using a sterile cotton pellet moistened with alcohol or saline as recommended by the manufacturer. Receives: Procedure: Calcium Hydroxide-based Sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Endodontic Pain Intensity
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48, and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start14 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion14 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Endodontic PainStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Rabie Ahmed, Minia University
- Investigators
- Dalia Ali Ahmed Moukarab, Professor, Study chair, Professor and Head of the Endodontics Department, Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767084
- Sponsor's protocol ID
- Post-Endodontic Pain
- Status last verified
- Apr 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Sealer Composition on Post-Endodontic Pain: A Prospective Comparative Analysis of Three Root Canal Sealers
- ClinicalTrials.gov ID
- NCT07767084
- Acronym / sponsor ID
- Post-Endodontic Pain
- Conditions
- Post Endodontic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 14 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 14 Apr 2027 (estimated)
- First posted
- 17 Aug 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.
Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life.
The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.
Detailed description
Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life .
The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week . The pathophysiology of postoperative pain involves mechanical, chemical, or microbial injury to the periapical tissues, which triggers an acute inflammatory response characterized by the release of inflammatory mediators, vasodilation, increased vascular permeability, and leukocyte migration, ultimately activating sensory neurons and generating pain.
The etiology of PP is multifactorial, including patient-related factors such as age, gender, tooth type particularly mandibular molars preoperative pain, and periapical radiolucency, as well as treatment-related factors such as instrumentation protocol, irrigation solution, working length determination, occlusal adjustment, number of visits, anesthesia type, and prophylactic analgesics. Understanding these variables allows clinicians to select techniques and materials that minimize postoperative discomfort.
Root canal obturation plays a critical role in postoperative pain, as sealers may come into direct contact with periradicular tissues or extrude through the apical foramen, eliciting cytotoxic and inflammatory responses . The chemical composition and biocompatibility of the sealer influence tissue reaction, periapical healing, and subsequent pain perception.
Traditionally, epoxy resin-based sealers, such as AH Plus®, have been considered the gold standard due to their excellent sealing properties, radiopacity, dimensional stability, and clinical performance; however, extrusion of these sealers has been associated with cytotoxicity and inflammation.
Calcium hydroxide-based sealers have long been used in endodontics, providing antibacterial effects, low cytotoxicity, and osteogenic and cementogenic potential, contributing to periapical repair.
More recently, calcium silicate-based bioceramic sealers, including tricalcium silicate formulations like BioRoot and EndoSeal MTA, have gained popularity due to their bioactivity, biocompatibility, ability to set in humid conditions, alkaline pH, calcium ion release, antimicrobial properties, and promotion of tissue regeneration with lower inflammatory mediator production.
These properties suggest that bioceramic sealers may reduce postoperative pain compared to traditional sealers, while supporting enhanced periapical healing and osteogenic induction.
Despite studies evaluating postoperative pain with different sealers, results remain controversial, and there is limited evidence specifically comparing the effects of epoxy resin-based versus calcium silicate-based sealers on pain outcomes following single-visit endodontic treatment.
This highlights a need for further randomized clinical trials to assess the incidence and severity of postoperative pain associated with these materials, particularly in patients with varying pulpal and periapical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Calcium Hydroxide-based Sealer: Sealapex): | Active comparator | Procedure: Calcium Hydroxide-based SealerAbout 22 cases will be subjected to: 1. Canals will be dried using sterile paper points, avoiding excessive desiccation to maintain optimal canal conditions prior to sealer placement. 2. The sealer will be dispensed according to the manufacturer's instructions. Gutta-percha master cones will be lightly coated with the sealer and inserted to the full working length. Additional sealer may be applied into the canal using a lentulo spiral or an appropriate intracanal delivery tip when indicated. 3. Accessory gutta-percha cones will be inserted into each canal to fill the spaces created by the spreader using a lateral compaction technique. 4. After achieving optimal obturation of the canal, excess gutta-percha will be seared off at the canal orifices using a heated instrument. 5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet moistened with saline. |
| Group B (Bioceramic Sealer: Well-Root): | Active comparator | Procedure: Calcium Hydroxide-based SealerAbout 22 cases will be subjected to: 1. Canals will be dried using sterile paper points, avoiding over drying to maintain slight moisture within the dentinal tubules, which is favorable for the setting reaction of the bioceramic sealer. 2. The premixed bioceramic sealer will be dispensed directly into the canal using the manufacturer's intracanal delivery tip adjusted to 1-2 mm short of the working length, or applied onto the master gutta-percha cone prior to insertion. 3. The master gutta-percha cone will be inserted to the full working length. Accessory cones will be placed when necessary using a lateral compaction technique to ensure complete canal obturation. 4. After achieving optimal filling, excess gutta-percha will be seared off at the canal orifices using a heat carrier. 5. Excess sealer will be removed from the pulp chamber using a sterile cotton pellet lightly moistened with saline. |
| Group C (Resin-based Sealer: ADSEAL): | Active comparator | Procedure: Calcium Hydroxide-based SealerAbout 22 cases will be subjected to: 1. Canals will be dried thoroughly using sterile paper points to ensure a moisture-free environment suitable for resin-based sealer application. 2. The resin-based sealer will be mixed according to the manufacturer's instructions and applied into the canal using a lentulo spiral or coated onto the master gutta-percha cone before insertion to the working length. 3. Accessory gutta-percha cones will be inserted using a lateral compaction technique to achieve dense canal obturation. 4. Excess gutta-percha will be removed at the canal orifices using a heated instrument after completion of obturation. 5. The pulp chamber will be cleaned from excess sealer using a sterile cotton pellet moistened with alcohol or saline as recommended by the manufacturer. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients requiring primary root canal treatment.
- Patients with acute irreversible pulpitis.
- Patients in good general health
Key exclusion criteria (4 listed)
- Patients with systemic diseases affecting pain perception or healing.
- Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment.
- Pregnant or lactating women.
- Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease
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 Hydroxide-based SealerAlso: Bioceramic Sealer and Resin-based Sealerto evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption. | Procedure or surgery | Group A (Calcium Hydroxide-based Sealer: Sealapex):, Group B (Bioceramic Sealer: Well-Root):, Group C (Resin-based Sealer: ADSEAL): |
Primary outcome
Post Endodontic Pain Intensity
Time frame: 7 days
Postoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48, and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study 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 17 Aug 2026.
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Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
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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.
Dalia Ali Ahmed Moukarab, Professor study chair
Professor and Head of the Endodontics Department, Faculty of Dentistry
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 Hydroxide-based Sealer in people with Post Endodontic Pain, run by Minia University at 1 site in Egypt.
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 4 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 17 Aug 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 Egypt. 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 Nourhan Rabie Ahmed Ahmed, B.D.S (+201148809567, nourhan.rabie93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Endodontic Pain Intensity (time frame: 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 17 Aug 2026.