Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06194773 |
| Other study ID # |
IRB-COD-STD-123-JUNE-2023 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 26, 2023 |
| Est. completion date |
January 6, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Gulf Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
