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The Effect of Totalfil and Neosealer Sealers on the Post-endodontic Pain

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.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06194773
Enrollment
39
Registered
2024-01-08
Start date
2023-06-26
Completion date
2025-01-06
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Brief 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. 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: 1. Patient history will be recorded before starting the procedure. 2. The consent form will be given and signed by the patient. 3. Pre-operative pain will be assessed using VAS. 4. Tooth diagnosis will take place through visualization, percussion, palpation, mobility, electric pulp test as well as cold test before the treatment begins. 5. Pre-operative radiograph will be taken to confirm diagnosis. 6. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine. The inferior alveolar nerve block will be administered. 7. 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). 8. The saliva ejector will be introduced below the integrated frame and will be positioned in the corner of the mouth. 9. De-roofing of the pulp chamber will be done using Endo Z bur. 10. 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. 11. All the canals will be prepared using Protaper Gold rotary system using NSK endodontic motor, according to the manufacturer guidelines. 12. To establish apical patency between the files during shaping we will use initial file size #10 between each instrument. 13. 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. 14. After completion of cleaning and shaping in all the canals will be flushed with a final rinse of NaOCl, saline and EDTA 17%. 15. For group 1, the canals will be moist and obturated using the single cone technique by gutta percha using Totalfill as a sealer. 16. For group 2, the canals will be moist and obturated using the single cone technique by gutta percha using Neosealer. 17. 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. 18. Final restoration will be placed. 19. 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.

Interventions

PROCEDURETotalfil

Root canal treatment using TotalFil sealer

PROCEDURENeoSealer

Root canal treatment using NeoSealer

PROCEDUREAH-Plus sealer

Root canal treatment using AH-Plus sealer

Sponsors

Gulf Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with mandibular molars diagnosed with symptomatic irreversible pulpitis.

Exclusion criteria

1. Medically compromised patients. 2. Pregnant patients. 3. Teeth with immature apex formation.

Design outcomes

Primary

MeasureTime frameDescription
The level of post-endodontic pain6 hoursEvaluation 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)

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026