Root Canal SealersNCT06798467
Evaluation of Post Obturation Pain Associated With Calcium Hydroxide-based Root Canal Sealers and Resin-based Root Canal Sealer: a Single Visit Root Canal Treatment
A study testing Endodontic sealer and post obturation pain in people with Root Canal Sealers and Post Operative Pain, run by Jinnah Sindh Medical University at 1 site in Pakistan.
Trial summary
The objective of this study is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Root Canal Sealers, Post Operative Pain, Irreversible Pulpitis
- What is being tested?
- Endodontic sealer and post obturation pain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Patients presenting with signs and symptoms of irreversible pulpitis in maxillary or mandibular teeth
- ≥18 years of age.
Who cannot join
- • Patients with any systemic diseases
- Retreatment cases
- Teeth with calcified canals.
- Medically compromised patient (with immunosuppressive/ systemic diseases, patient on medication)
- Patients on analgesics or sedative medication prior to root canal therapy.
- Patients in whom single visit endodontic treatment will not be possible
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Oral Health Sciences Jinnah Sindh Medical University Karachi
Karcahi, Sindh, 75510
About this study
Official title: An in Vivo "Evaluation of Post Obturation Pain Associated With Calcium Hydroxide-based Root Canal Sealers and Resin-based Root Canal Sealer: a Single Visit Root Canal Treatment
The objective of this study is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale.
Methods: This study was designed as single blind, randomized control trial. Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on root canal sealer used during endodontic treatment: calcium hydroxide-based root canal sealer and resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48hours on the visual analogue scale (VAS).
Read the detailed description
Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment1 and its occurrence was noted to vary between 3 and 58%.2 3 The causes of postoperative pain is related to post obturation pain and can be classified as mechanical, chemical and/or microbiological injuries to the peri-radicular tissues.Factors identified that contribute to post-operative pain after single- visit root canal treatment consist of the following: age, sex, tooth type or location. Intraoperative factors include the physical properties of endodontic instruments used in the initial treatment, features of irrigation protocol like chemical solutions and concentrations, microbiological stability and resistance, histopathological state of the tissues surrounding the tooth, etc.6 During the obturation phase of root canal therapy, the endodontic sealer makes direct and local contact with the reshaped periapical tissues through the apical foramen and any supplementary lateral canals. By understanding the factors that contribute to postoperative pain, dental practitioners may better choose procedures and supplies that have been shown to reduce the occurrence of this symptom.7 Pain perception is mainly a subjective and variable experience that depends on many psychological and physical factors. The visual analog scale (VAS) is usually used as a measure of pain intensity in clinical researches due to its simplicity. The VAS intensity rating consisted of a 100-mm length line with two end points as no pain and worst pain. 8 An ideal root canal sealer should be capable of creating an effective bond to the GP and root canal walls to prevent microleakage at the interface.9 Biocompatibility and bioactivity are essential properties for root canal sealers, as these materials are in close proximation with the surrounding tissues and affect the repair.10 If the sealers are biocompatible and soluble in tissue fluid, minimal extrusions could be tolerated by the peri-radicular tissues.11 Sealers placed in the root canals interfere with periodontal tissues through the apical foramina, lateral canals, or leaching and can potentially affect the healing process in the periodontium Thus, the local inflammation caused by root canal obturation materials may result in postoperative pain. The intensity of inflammatory reactions depends on a number of different factors, including the composition of the sealer. 12 Therefore, root canal sealers may have a role in the discomfort felt after having a root canal. Pain sensations and flare-ups may be triggered by root canal sealers due to the stimulation of trigeminal nociceptors in vitro and the accompanying immunologic response, as proposed by Ruparel et al13 The un-polymerized residues remain due to formation of oxygen inhibition layer in the mixture of AH Plus sealer, which is responsible for maintaining its toxic effect.14 Sealapex is one of calcium hydroxide based root canal sealer having cytotoxic potential. After setting Sealapex becomes unstable and disintegrates.15 Khatri S1 in his study stated that AH Plus was associated with the highest pain intensity post 12 hours evaluation 5.00±1.124. This signifies the increased toxic effect of AH Plus sealer then Sealapex. AH Plus contains both epoxy resins and amines which have toxic effect. A randomized controlled clinical investigation by Ates et al16 including both vital and non-vital mandibular premolars and molars found a 68% and 59% prevalence of patients experiencing discomfort in teeth filled with AH Plus sealer.
The aim of this in-vivo study is to compare and evaluate the effect of AH Plus and Sealapex sealers on postoperative pain. Given the conflicting findings and lack of data in the endodontic literature on this issue, we decided to investigate the connection between endodontic sealers and postoperative discomfort. The purpose of this randomized clinical trial was to evaluate the effectiveness of two root canal sealer AH Plus and sealapex in reducing postoperative pain and the need for analgesics following root canal treatment.
- Being tested
- Endodontic sealer, post obturation pain
- Keywords
- root canal sealers, post operative pain, symptomatic periapical periodontitis, calcium hydroxide sealer, resin-based root canal sealer, visual analogue scale
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic sealerOther
endodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies.
post obturation painOther
Unpleasant sensation of any degree of pain after root canal treatment.
| Study group | Role | What they receive |
|---|---|---|
| post obturation pain | Active comparator | Unpleasant sensation of any degree of pain after root canal treatment. Receives: Other: Endodontic sealer |
| endodontic sealer | Active comparator | endodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies. Receives: Other: post obturation pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of post obturation pain associated with calcium hydroxide-based root canal sealers and resin-based root canal sealer: a single visit root canal treatment.
Introduction: Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment and its occurrence was noted to vary between 3 and 58%. The objective is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale.
Methods: This study was designed as single blind, randomized control trial .Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on irrigation protocols used during endodontic treatment: calcium hydroxide-based rootand resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48 hours on the visual analogue scale (VAS).
Measured: 6 hours, 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Oct 2024
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Root Canal SealersStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Sindh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soha Pirzado, Jinnah Sindh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798467
- Sponsor's protocol ID
- JSMU/IRB/2024/971
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Khatri S, Parvez S, Agarwal MK, Goyal D, Binawra KK, Jain A, et al. Comparative Evaluation of Effect of Resinbased, Calcium Hydroxide-Based and Bioceramic-Based Root Canal Sealers on Postoperative Pain. List of Articles Pages No.2022;11(1) :54-61
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An in Vivo "Evaluation of Post Obturation Pain Associated With Calcium Hydroxide-based Root Canal Sealers and Resin-based Root Canal Sealer: a Single Visit Root Canal Treatment
- ClinicalTrials.gov ID
- NCT06798467
- Acronym / sponsor ID
- JSMU/IRB/2024/971
- Keywords
- root canal sealers, post operative pain, symptomatic periapical periodontitis, calcium hydroxide sealer, resin-based root canal sealer, visual analogue scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Jinnah Sindh Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 29 Jan 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 objective of this study is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale.
Methods: This study was designed as single blind, randomized control trial. Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on root canal sealer used during endodontic treatment: calcium hydroxide-based root canal sealer and resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48hours on the visual analogue scale (VAS).
Detailed description
Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment1 and its occurrence was noted to vary between 3 and 58%.2 3 The causes of postoperative pain is related to post obturation pain and can be classified as mechanical, chemical and/or microbiological injuries to the peri-radicular tissues.Factors identified that contribute to post-operative pain after single- visit root canal treatment consist of the following: age, sex, tooth type or location. Intraoperative factors include the physical properties of endodontic instruments used in the initial treatment, features of irrigation protocol like chemical solutions and concentrations, microbiological stability and resistance, histopathological state of the tissues surrounding the tooth, etc.6 During the obturation phase of root canal therapy, the endodontic sealer makes direct and local contact with the reshaped periapical tissues through the apical foramen and any supplementary lateral canals. By understanding the factors that contribute to postoperative pain, dental practitioners may better choose procedures and supplies that have been shown to reduce the occurrence of this symptom.7 Pain perception is mainly a subjective and variable experience that depends on many psychological and physical factors. The visual analog scale (VAS) is usually used as a measure of pain intensity in clinical researches due to its simplicity. The VAS intensity rating consisted of a 100-mm length line with two end points as no pain and worst pain. 8 An ideal root canal sealer should be capable of creating an effective bond to the GP and root canal walls to prevent microleakage at the interface.9 Biocompatibility and bioactivity are essential properties for root canal sealers, as these materials are in close proximation with the surrounding tissues and affect the repair.10 If the sealers are biocompatible and soluble in tissue fluid, minimal extrusions could be tolerated by the peri-radicular tissues.11 Sealers placed in the root canals interfere with periodontal tissues through the apical foramina, lateral canals, or leaching and can potentially affect the healing process in the periodontium Thus, the local inflammation caused by root canal obturation materials may result in postoperative pain. The intensity of inflammatory reactions depends on a number of different factors, including the composition of the sealer. 12 Therefore, root canal sealers may have a role in the discomfort felt after having a root canal. Pain sensations and flare-ups may be triggered by root canal sealers due to the stimulation of trigeminal nociceptors in vitro and the accompanying immunologic response, as proposed by Ruparel et al13 The un-polymerized residues remain due to formation of oxygen inhibition layer in the mixture of AH Plus sealer, which is responsible for maintaining its toxic effect.14 Sealapex is one of calcium hydroxide based root canal sealer having cytotoxic potential. After setting Sealapex becomes unstable and disintegrates.15 Khatri S1 in his study stated that AH Plus was associated with the highest pain intensity post 12 hours evaluation 5.00±1.124. This signifies the increased toxic effect of AH Plus sealer then Sealapex. AH Plus contains both epoxy resins and amines which have toxic effect. A randomized controlled clinical investigation by Ates et al16 including both vital and non-vital mandibular premolars and molars found a 68% and 59% prevalence of patients experiencing discomfort in teeth filled with AH Plus sealer.
The aim of this in-vivo study is to compare and evaluate the effect of AH Plus and Sealapex sealers on postoperative pain. Given the conflicting findings and lack of data in the endodontic literature on this issue, we decided to investigate the connection between endodontic sealers and postoperative discomfort. The purpose of this randomized clinical trial was to evaluate the effectiveness of two root canal sealer AH Plus and sealapex in reducing postoperative pain and the need for analgesics following root canal treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post obturation pain | Active comparator | Other: Endodontic sealerUnpleasant sensation of any degree of pain after root canal treatment. |
| endodontic sealer | Active comparator | Other: post obturation painendodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Patients presenting with signs and symptoms of irreversible pulpitis in maxillary or mandibular teeth
Key exclusion criteria (6 listed)
- • Patients with any systemic diseases
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 |
|---|---|---|
| Endodontic sealerendodontic sealer is a material used in root canal therapy to fill the microscopic spaces between the root canal filling material (typically gutta-percha) and the walls of the root canal. Its primary function is to create a tight seal that prevents the ingress of bacteria and fluids into the root canal system, helping to prevent reinfection and promoting the healing of periapical tissues. Endodontic sealers also help to ensure that the root canal filling reaches all parts of the canal, especially in complex or irregularly shaped anatomies. | Other | post obturation pain |
| post obturation painUnpleasant sensation of any degree of pain after root canal treatment. | Other | endodontic sealer |
Primary outcome
Evaluation of post obturation pain associated with calcium hydroxide-based root canal sealers and resin-based root canal sealer: a single visit root canal treatment.
Time frame: 6 hours, 24 hours and 48 hours
Introduction: Modern endodontics offers advancements in technologies, procedures and materials. Post-obturation pain is defined as pain of any degree that occurs after initiation of root canal treatment and its occurrence was noted to vary between 3 and 58%. The objective is to evaluate the post obturation pain associated with calcium hydroxide-based root canal sealer and resin-based root canal sealer after single visit root canal treatment following endodontic treatment by means of Visual Analog Scale. Methods: This study was designed as single blind, randomized control trial .Sixty patients with irreversible pulpitis requiring endodontic canal treatment were recruited by probability random sampling into two groups based on irrigation protocols used during endodontic treatment: calcium hydroxide-based rootand resin-based root canal sealer . The post-operative pain of patients was recorded via a telephone call at 6 hours, 24 hours, and at 48 hours on the visual analogue scale (VAS).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- BackgroundKhatri S, Parvez S, Agarwal MK, Goyal D, Binawra KK, Jain A, et al. Comparative Evaluation of Effect of Resinbased, Calcium Hydroxide-Based and Bioceramic-Based Root Canal Sealers on Postoperative Pain. List of Articles Pages No.2022;11(1) :54-61
- Individual participant dataSharing planned: Yes
Related trials for Root Canal Sealers
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Effect of Instrumentation Systems and Sealers on Postoperative Pain
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Postoperative Pain After Root Canal Treatment Using Different Root Canal Sealers
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endodontic sealer and post obturation pain in people with Root Canal Sealers and Post Operative Pain, run by Jinnah Sindh Medical University 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 2 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: finished, as of the sponsor's last update on 30 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of post obturation pain associated with calcium hydroxide-based root canal sealers and resin-based root canal sealer: a single visit root canal treatment. (time frame: 6 hours, 24 hours and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798467, which also lists 1 linked publication.
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 30 Apr 2025.