Effect of cold saline irrigation during root canal treatment on postoperative pain in symptomatic teeth

Phase 4

• Conditions: Acute apical periodontitis of pulpal origin,

• Registration Number: CTRI/2019/07/020045
• Lead Sponsor: Dr Samrita Shrestha

Brief Summary

One of the aims of the endodontic therapy is to reducepostoperative pain and reduce the inflammation. Postoperative painfollowing root canal treatment can be embarrassing for the dentist and annoyingfor the patient. Despiteacceptable standards of endodontic therapy, occurrence of mild intensity postoperative pain is a common event. Postoperativepain is multifactorial yet it can be predicted especially in teeth with pulpnecrosis, preoperative pain and symptomatic apical periodontitis. One novel way to reverse the inflammatory process andcontrol pain is cryotherapy. Cryotherapy has reduced the incidence ofpostoperative pain and the need for medication in patients as well.  In this study, patients who will meet all inclusion criteria and noneof the exclusion criteria will be randomly assigned into two groups by means ofcomputer generated random number.

**GroupI**will be the experimental group that will receive a final irrigation with cold(2.5°C) sterilesaline solution.

**GroupII**will be the control group that will receive a final irrigation with sterilesaline solution at room temperature.

Root canal treatment will be performed as per the standard protocol. Follow up of subjectwill be done at 6, 12, 24, 48 and 72 hours post-operatively. Preoperative and postoperative pain score will recorded following the numeric pain rating score.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-04-07
• Study Start: 2019-07-20

Recruitment & Eligibility

• Status: Not Applicable
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• Nepalese patients older than 18 years of age 2.
• Only patients presenting with uniradicular teeth with a single canal and a diagnosis of necrotic pulp and symptomatic apical periodontitis 3.
• Only those patients registering from 4 to 10 on the preoperative NRS will be included 4.
• Patient who can understand and provide informed consent.

Exclusion Criteria

• Patient not willing to participate in the study 2.
• Patients whose forms will be incompletely or inadequately filled out 3.
• Pregnancy 4.
• A history of medication for chronic pain 5.
• Immunocompromised patient 6.
• Patients with special needs and medical conditions altering the protocol 7.
• Root canal re-treatment 8.
• Root canals with an extreme curvature [>30] 10.
• Internal or external resorption 11.
• Teeth with open apices 12.
• A radiographically untraceable canal path 13.
• Any accident or complication occurring during treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The effect of intracanal cryotherapy on postoperative pain in teeth with symptomatic apical periodontitis will be measured as the changes from baseline.	6, 12, 24, 48 and 72 hours post-operatively

Secondary Outcome Measures

Name	Time	Method
The effect of intracanal cryotherapy and room temperature sterile saline solution as an intracanal irrigant on postoperative pain in different time interval will be measured.	6, 12, 24, 48 and 72 hours post-operatively

Trial Locations

Locations (1)

B.P. Koirala Institute of Health Sciences; 🇮🇳 Dharan,, India

B.P. Koirala Institute of Health Sciences

🇮🇳Dharan,, India

Dr Samrita Shrestha

Principal investigator

9779841491991

drsamrita.shrestha@gmail.com