Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain
NCT ID: NCT06090500
Last Updated: 2024-02-08
Study Results
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Basic Information
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COMPLETED
NA
52 participants
INTERVENTIONAL
2023-03-20
2024-01-30
Brief Summary
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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.
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Detailed Description
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Group I: (Diclofenac Sodium) submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) after the normal local anaesthetic routine.
Group II: (Dexamethasone) Submucosal infiltration injection of 1 ml dexamethasone sodium phosphate (4mg/ml) 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 5°C 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 1:100,000 epinephrine.
3. In group I submucosal infiltration injection of 1 ml diclofenac sodium (25mg/ml) 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 (4mg/ml) 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 5°C) 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 5.25% 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Submucosal Cryotherapy
preoperative submucosal infiltration injection of (2.5C-5C) cold saline
Cryotherapy
preoperative submucosal infiltration injection of cold saline solution (2-5 degrees Celsius)
Submucosal NSAIDs
preoperative submucosal infiltration injection of Diclofenac sodium
Diclofenac sodium
preoperative submucosal infiltration injection of Diclofenac sodium (25mg/ml)
Submucosal corticosteroids
preoperative submucosal infiltration injection of dexamethasone
Dexamethasone sodium phosphate
preoperative submucosal infiltration injection of dexamethasone sodium phosphate (4mg/ml)
Control
no preoperative injection apart from the normal anaesthetic routine
No interventions assigned to this group
Interventions
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Cryotherapy
preoperative submucosal infiltration injection of cold saline solution (2-5 degrees Celsius)
Diclofenac sodium
preoperative submucosal infiltration injection of Diclofenac sodium (25mg/ml)
Dexamethasone sodium phosphate
preoperative submucosal infiltration injection of dexamethasone sodium phosphate (4mg/ml)
Eligibility Criteria
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Inclusion Criteria
* Patients age (18- 50) years old.
* Maxillary premolar teeth diagnosed with symptomatic irreversible pulpitis.
* No clinical or radiographic evidence of periapical nor periodontal pathosis.
* Compliant patient.
Exclusion Criteria
* Analgesics or anti-inflammatory drugs taken within 24 h before the intervention.
* Over instrumentation during treatment.
* Long-term use of corticosteroids.
* Access revealing necrotic tooth indicating a false positive diagnosis.
* Sensitivity to any of the pharmaceuticals intended to be used in this study.
* Intra operative complications such as canal calcification, or loss of apical Patency.
18 Years
50 Years
ALL
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mai Shalabi
Teaching Assistant in the department of endodontics faculty of dentistry ASU
Locations
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Ain Shams University
Cairo, , Egypt
Countries
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Other Identifiers
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FDASU 1234
Identifier Type: -
Identifier Source: org_study_id
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