Effect of Submucosal Cryotherapy on Postoperative Endodontic Pain
Condition: Post-endodontic Pain
Study type: Interventional

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.
    

Detailed description: 
      The study will be conducted on 52 maxillary premolar teeth; with 13 maxillary premolars in
      each group (n=13). 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 group/used sub-mucosal injection.

      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
    

Intervention name(s): Cryotherapy; Diclofenac sodium; Dexamethasone sodium phosphate
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): preoperative submucosal infiltration injection of cold saline solution (2-5 degrees Celsius); preoperative submucosal infiltration injection of Diclofenac sodium (25mg/ml); preoperative submucosal infiltration injection of dexamethasone sodium phosphate (4mg/ml)
Intervention MeSH terms: Dexamethasone; Diclofenac; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: submucosal injection of cold saline 2 to 5 degrees celsius for cryotherapy
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment