Irreversible PulpitisNCT06194773
The Effect of Totalfil and Neosealer Sealers on the Post-endodontic Pain
A study testing Totalfil, NeoSealer and AH-Plus sealer in people with Irreversible Pulpitis, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
The goal of this clinical trial is to evaluate the effect of Totalfil and Neosealer sealers on post-endodontic pain compared to AH plus sealer in mandibular molars with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Totalfil, NeoSealer and AH-Plus sealer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 26 Jun 2023to 6 Jan 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.
Who cannot join
- Medically compromised patients.
- Pregnant patients.
- Teeth with immature apex formation.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
About this study
Official title: Evaluation of the Effect of Totalfil and Neosealer Sealers on the Post-endodontic Pain in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis; a Randomized Control Study.
The goal of this clinical trial is to evaluate the effect of Totalfil and Neosealer sealers on post-endodontic pain compared to AH plus sealer in mandibular molars with symptomatic irreversible pulpitis. The main question: do Totalfil and Neosealer sealers affect postoperative pain intensity after root canal treatment in mandibular molars with symptomatic irreversible pulpitis? Participants will undergo root canal treatment using totalfil, Neosealer, or AH-Plus sealer. Researchers will compare Totalfil, Neosealer, and AH-Plus to assess the intensity of post-endodontic pain.
Read the detailed description
The study will be conducted on 39 mandibular molars; with 13 mandibular mandibular molars in each group (n=13). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group/used root canal sealer.
Group I: Endodontic treatment with obturation using single cone technique with Totalfil sealer.
Group 2: Endodontic treatment with obturation using single cone technique with Neosealer.
Group 3: Endodontic treatment with obturation using single cone technique with AH plus sealer.
Clinical procedure:
- Patient history will be recorded before starting the procedure.
- The consent form will be given and signed by the patient.
- Pre-operative pain will be assessed using VAS.
- Tooth diagnosis will take place through visualization, percussion, palpation, mobility, electric pulp test as well as cold test before the treatment begins.
- Pre-operative radiograph will be taken to confirm diagnosis.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine. The inferior alveolar nerve block will be administered.
- A single tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond stone (NO173).
- The saliva ejector will be introduced below the integrated frame and will be positioned in the corner of the mouth.
- De-roofing of the pulp chamber will be done using Endo Z bur.
- After removal of the pulp tissue using an H-file, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- All the canals will be prepared using Protaper Gold rotary system using NSK endodontic motor, according to the manufacturer guidelines.
- To establish apical patency between the files during shaping we will use initial file size #10 between each instrument.
- Each canal will be irrigated with 30 mL 3% NaOCl and flushed with saline 10 mL between each file during the whole preparation procedure using a plastic syringe with a side vented needle.
- After completion of cleaning and shaping in all the canals will be flushed with a final rinse of NaOCl, saline and EDTA 17%.
- For group 1, the canals will be moist and obturated using the single cone technique by gutta percha using Totalfill as a sealer.
- For group 2, the canals will be moist and obturated using the single cone technique by gutta percha using Neosealer.
- For group 3, the canals will be dried using suitable size of paper points, followed by obturation using single cone technique using AH plus as a sealer.
- Final restoration will be placed.
- Post-operative pain will be accessed using The Visual Analogue Scale (VAS), after 6, 24, 48, 72 hours, and 7 days. Any analgesic pills taken by the patient will be reported.
- Conditions
- Irreversible Pulpitis
- Being tested
- Totalfil, NeoSealer, AH-Plus sealer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TotalfilProcedure or surgery
Root canal treatment using TotalFil sealer
NeoSealerProcedure or surgery
Root canal treatment using NeoSealer
AH-Plus sealerProcedure or surgery
Root canal treatment using AH-Plus sealer
| Study group | Role | What they receive |
|---|---|---|
| Totalfil | Experimental | Not described Receives: Procedure: Totalfil |
| NeoSealer | Experimental | Not described Receives: Procedure: NeoSealer |
| AH-Plus | Active comparator | Not described Receives: Procedure: AH-Plus sealer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
Measured: 6 hours
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
Measured: 24 hours
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
Measured: 48 hours
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
Measured: 72 hours
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
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 posted8 Jan 2024
- Study start26 Jun 2023
- Primary completion6 Dec 2024
- Study completion6 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194773
- Sponsor's protocol ID
- IRB-COD-STD-123-JUNE-2023
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Totalfil and Neosealer Sealers on the Post-endodontic Pain in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis; a Randomized Control Study.
- ClinicalTrials.gov ID
- NCT06194773
- Acronym / sponsor ID
- IRB-COD-STD-123-JUNE-2023
- Conditions
- Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 8 Jan 2024 (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 evaluate the effect of Totalfil and Neosealer sealers on post-endodontic pain compared to AH plus sealer in mandibular molars with symptomatic irreversible pulpitis. The main question: do Totalfil and Neosealer sealers affect postoperative pain intensity after root canal treatment in mandibular molars with symptomatic irreversible pulpitis? Participants will undergo root canal treatment using totalfil, Neosealer, or AH-Plus sealer. Researchers will compare Totalfil, Neosealer, and AH-Plus to assess the intensity of post-endodontic pain.
Detailed description
The study will be conducted on 39 mandibular molars; with 13 mandibular mandibular molars in each group (n=13). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the assessor and the patients will not be aware of their group/used root canal sealer.
Group I: Endodontic treatment with obturation using single cone technique with Totalfil sealer.
Group 2: Endodontic treatment with obturation using single cone technique with Neosealer.
Group 3: Endodontic treatment with obturation using single cone technique with AH plus sealer.
Clinical procedure:
- Patient history will be recorded before starting the procedure.
- The consent form will be given and signed by the patient.
- Pre-operative pain will be assessed using VAS.
- Tooth diagnosis will take place through visualization, percussion, palpation, mobility, electric pulp test as well as cold test before the treatment begins.
- Pre-operative radiograph will be taken to confirm diagnosis.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine. The inferior alveolar nerve block will be administered.
- A single tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond stone (NO173).
- The saliva ejector will be introduced below the integrated frame and will be positioned in the corner of the mouth.
- De-roofing of the pulp chamber will be done using Endo Z bur.
- After removal of the pulp tissue using an H-file, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- All the canals will be prepared using Protaper Gold rotary system using NSK endodontic motor, according to the manufacturer guidelines.
- To establish apical patency between the files during shaping we will use initial file size #10 between each instrument.
- Each canal will be irrigated with 30 mL 3% NaOCl and flushed with saline 10 mL between each file during the whole preparation procedure using a plastic syringe with a side vented needle.
- After completion of cleaning and shaping in all the canals will be flushed with a final rinse of NaOCl, saline and EDTA 17%.
- For group 1, the canals will be moist and obturated using the single cone technique by gutta percha using Totalfill as a sealer.
- For group 2, the canals will be moist and obturated using the single cone technique by gutta percha using Neosealer.
- For group 3, the canals will be dried using suitable size of paper points, followed by obturation using single cone technique using AH plus as a sealer.
- Final restoration will be placed.
- Post-operative pain will be accessed using The Visual Analogue Scale (VAS), after 6, 24, 48, 72 hours, and 7 days. Any analgesic pills taken by the patient will be reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Totalfil | Experimental | Procedure: Totalfil |
| NeoSealer | Experimental | Procedure: NeoSealer |
| AH-Plus | Active comparator | Procedure: AH-Plus sealer |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.
Key exclusion criteria (3 listed)
- Medically compromised patients.
- Pregnant patients.
- Teeth with immature apex formation.
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 |
|---|---|---|
| TotalfilRoot canal treatment using TotalFil sealer | Procedure or surgery | Totalfil |
| NeoSealerRoot canal treatment using NeoSealer | Procedure or surgery | NeoSealer |
| AH-Plus sealerRoot canal treatment using AH-Plus sealer | Procedure or surgery | AH-Plus |
Primary outcome
The level of post-endodontic pain
Time frame: 6 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
The level of post-endodontic pain
Time frame: 24 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
The level of post-endodontic pain
Time frame: 48 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
The level of post-endodontic pain
Time frame: 72 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
The level of post-endodontic pain
Time frame: 7 days
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10 cm with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could be)
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 14 Sep 2026.
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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 Totalfil, NeoSealer and AH-Plus sealer in people with Irreversible Pulpitis, run by Gulf Medical University at 1 site in United Arab Emirates.
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 1 inclusion and 3 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 14 Sep 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 United Arab Emirates. 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?
The level of post-endodontic pain (time frame: 6 hours). The study lists 5 primary outcomes in all. 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 14 Sep 2026.