Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05722704 |
| Other study ID # |
IRB/COD/STD/14/May-2022 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 12, 2022 |
| Est. completion date |
December 12, 2023 |
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 compare Cryotherapy with occlusal reduction in the
reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main
question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal
reduction in patients with symptomatic apical periodontitis on mandibular first molars?
Participants will undergo root canal treatment including cryotherapy or post-operative
occlusal reduction.
Researchers will compare [Cryotherapy, occlusal reduction, and no intervention] to see the
intensity of post-endodontic pain.
Description:
The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in
each group (n=20). 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 operator
and the patients will not be aware of their group/used root canal irrigant.
Group I : normal room temperature saline irrigation protocol without occlusal reduction.
Group II : normal room temperature saline irrigation protocol with occlusal reduction.
Group III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.
Procedural steps:
1. Vitality will be assessed using cold tests and electric pulp testing before the
procedure is carried out. Besides, mobility, palpation, and percussion tests will be
done to assess periapical health. In order to ensure that the cold and electrical pulp
tests are working, and a response is elicited, both tests will be carried out on
patients not included in the study.
2. All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
3. Each 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 bur under copious water.
4. After removal of coronal pulp tissues using a sterile excavator, 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.
5. Hand instrumentation to 15-size K files.
6. All the canals will be prepared using ProTaper Gold rotary files till the master apical
file F2.
7. Apical patency will be maintained throughout the shaping procedure using the #10 file
between each instrument.
8. All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the
whole preparation procedure.
9. In group I the root canals will be obturated directly after preparation.
10. In group II occlusal reduction will be performed after root canal preparation.
11. For group III the root canals will be irrigated for 5 min using 20 ml cryo-treated
saline maintained at a temperature of 2°C-4°C.
12. After completion of cleaning and shaping dried using appropriate size paper points and
the canals will be obturated using gutta-percha, and restored by permanent composite
restoration.
