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

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.
    

Detailed 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.
    

Intervention name(s): Cryotherapy; Occlusal reduction
Intervention type(s): Procedure; Procedure
Intervention description(s): Final irrigation with cold saline (2.5C-4C) without occlusal reduction; Reduction of the functional and non-functional cusps
Intervention MeSH terms: Salicylic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post endodontic pain; Cryotherapy; Occlusal reduction; Root canal treatment