Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06090500
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2023-10-10
Brief Title:
Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Effect of Submucosal Cryotherapy Compared to Steroidal and Non-Steroidal Anti-Inflammatory Drugs Injection on Postoperative Endodontic Pain
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare submucosal Cryotherapy with different anti-inflammatory drugs in the reduction of post-endodontic pain in upper premolars with symptomatic irreversible pulpitis
The main question it aims to answer is
Is there is a difference in post-endodontic pain intensity following submucosal cryotherapy or anti-inflammatory drugs injection in patients with symptomatic irreversible pulpitis Participants will undergo root canal treatment preceded by preoperative injection of cold saline cryotherapy or preoperative injection of anti-inflammatory drugs Researchers will compare Cryotherapy Non steroidal anti-inflammatory drugs steroids and no intervention to see the intensity of post-endodontic pain
The main question it aims to answer is
Is there is a difference in post-endodontic pain intensity following submucosal cryotherapy or anti-inflammatory drugs injection in patients with symptomatic irreversible pulpitis Participants will undergo root canal treatment preceded by preoperative injection of cold saline cryotherapy or preoperative injection of anti-inflammatory drugs Researchers will compare Cryotherapy Non steroidal anti-inflammatory drugs steroids and no intervention to see the intensity of post-endodontic pain
Detailed Description:
The study will be conducted on 52 maxillary premolar teeth with 13 maxillary premolars in each group n13 An independent individual withholding the random allocation sequence will preoperatively inform a second individual responsible for injection about the solution required to be injected according to the patient number in the preformed randomized sequence Triple blinding will be maintained in this study as the operator the patients and the outcome assessor will not be aware of their groupused sub-mucosal injection
Group I Diclofenac Sodium submucosal infiltration injection of 1 ml diclofenac sodium 25mgml after the normal local anaesthetic routine
Group II Dexamethasone Submucosal infiltration injection of 1 ml dexamethasone sodium phosphate 4mgml after the normal local anaesthetic routine
Group III Cryotherapy Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5C after the normal local anaesthetic routine
Group IV Negative control Patients received no injection apart from the normal local anaesthetic routine
Procedural steps
1 Vitality will be assessed using cold tests 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 4 Articaine hydrochloride with 1100000 epinephrine
3 In group I submucosal infiltration injection of 1 ml diclofenac sodium 25mgml will be given in the depth of the vestibule 5 minutes after local anesthetic injection
4 In group II submucosal infiltration injection of 1 ml dexamethasone sodium phosphate 4mgml will be given in the depth of the vestibule 5 minutes after local anesthetic injection
5 In group III submucosal infiltration injection of 1 mL 2 to 5C cold saline will be given in the depth of the vestibule 5 minutes after local anesthetic injection
6 In group IV regular endodontic treatment starts 5 minutes after local anesthetic injection
7 Each tooth will be isolated using a rubber dam and the access cavity will be prepared using a tapered diamond stone with rounded end under copious water cooling
8 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
9 Hand instrumentation to 15-size K files
10 All the canals will be prepared using M-Pro Gold rotary files till the master apical file
11 Apical patency will be maintained throughout the shaping procedure using the 10 file between each instrument
12 All the canals will be irrigated with 10 mL of 525 NaOCl between each file during the whole preparation procedure
13 After completion of cleaning and shaping canals will be dried using appropriate size paper points and obturated using gutta-percha with cold lateral technique then restored by temporary restoration
Group I Diclofenac Sodium submucosal infiltration injection of 1 ml diclofenac sodium 25mgml after the normal local anaesthetic routine
Group II Dexamethasone Submucosal infiltration injection of 1 ml dexamethasone sodium phosphate 4mgml after the normal local anaesthetic routine
Group III Cryotherapy Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5C after the normal local anaesthetic routine
Group IV Negative control Patients received no injection apart from the normal local anaesthetic routine
Procedural steps
1 Vitality will be assessed using cold tests 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 4 Articaine hydrochloride with 1100000 epinephrine
3 In group I submucosal infiltration injection of 1 ml diclofenac sodium 25mgml will be given in the depth of the vestibule 5 minutes after local anesthetic injection
4 In group II submucosal infiltration injection of 1 ml dexamethasone sodium phosphate 4mgml will be given in the depth of the vestibule 5 minutes after local anesthetic injection
5 In group III submucosal infiltration injection of 1 mL 2 to 5C cold saline will be given in the depth of the vestibule 5 minutes after local anesthetic injection
6 In group IV regular endodontic treatment starts 5 minutes after local anesthetic injection
7 Each tooth will be isolated using a rubber dam and the access cavity will be prepared using a tapered diamond stone with rounded end under copious water cooling
8 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
9 Hand instrumentation to 15-size K files
10 All the canals will be prepared using M-Pro Gold rotary files till the master apical file
11 Apical patency will be maintained throughout the shaping procedure using the 10 file between each instrument
12 All the canals will be irrigated with 10 mL of 525 NaOCl between each file during the whole preparation procedure
13 After completion of cleaning and shaping canals will be dried using appropriate size paper points and obturated using gutta-percha with cold lateral technique then restored by temporary restoration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None