Effectiveness of Cryotherapy on Endodontic Pain (Cy)

Effectiveness of Intracanal Cryotherapy on Post Operative Pain After Root Canal Therapy in Patients with Symptomatic Apical Periodontitis

This is a randomized , prospective , control trial to assess the effectiveness of intracanal cryotherapy on post operative pain after root canal treatment in patients with symptomatic apical periodontitis

Study Overview

• Status: Recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Drug: Irrigation Solution

Detailed Description

Diagnostic procedures to include patients history taking , clinical and radiographic with all findings being recorded in patients .

patients diagnosed with symptomatic irreversible pulpitis with symptomatic apical periodontitis.

patients will be asked to rate their pre treatment pain on visual analogue scale from 0-10

patients with pain score <8 will be considered

Anesthesia and isolation : after administration of local anesthesia , rubber dam application will be done

Acess cavity : acess will be gained with round bur using air turbune handpiece with copious water cooling

Working length : a size 10k file will be inserted into the canal to determine the working length with the help of radiograph

Cleaning and shaping : Extirpation of pulp will be done followed by canal preparation with manual and endodontic motor using naocl and EDTA .

final irrigation will be performed using 17% EDTA and 5.25% NaOCl

Patients will be divided into 2 group in control group : final irrigation will be done using 5ml of saline at room temperature in cold group : final irrigation will be done using 5ml of cold saline at 2.5°C

the solution will be stored in the refrigerator until use irrigation will be performed for 5 min in both groups using 27 G beveled needle tip inserted 2mm short of WL.

Obturation ; In both groups , canals will be dried with paper points and obturated using gutta percha cones with zinc oxide eugenol sealer

Restoration : acces cavity will be restroed with direct composite restoration or high viscosity glass ionomer cement

each patient will be given instruction to acess the post operative pain .

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hira Amjad, BDS; Phone Number: 03345294071; Email: anmolamjad03@gmail.com
• Study Contact Backup: Name: Kanza Zafar, BDS; Phone Number: 03337808809; Email: kanzazafar6@gmail.com

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Recruiting
      • Armed Forces Institute of Dentistry
      • Contact: Hira Amjad, BDS; Phone Number: 03345294071; Email: anmolamjad03@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis
• maxillary or mandibular single rooted teeth
• systemically healthy patients
• patients having pain score < 8

Exclusion Criteria:

• patients on preoperative analgesics or antibiotics within past 12 hours
• teeth with calcified canals and previously treated teeth
• tooth with immature apices or resorption
• patients allergic to local anesthesia
• pregnant or lactating mothers
• patients who are immunocompromised .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: normal saline group; In control group , canals will be irrigated with 5ml of normal saline at room temperature	Drug: Irrigation Solution; normal saline will be used as irrigation solution; Other Names: normal saline irrigant
Experimental: cryotherapy (cold saline group); in cold saline group , canals will be irrigated with 5 ml of cold saline at a temperature of 2.5° C	Drug: Irrigation Solution; normal saline will be used as irrigation solution; Other Names: normal saline irrigant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post operative pain after root canal treatment	post operative pain will be assessed using visual analogue scale ( VAS) from 0-10 each patient will be given instruction to access the post operative pain . it will be carried out using a questionnaire. VAS 0-1 = No pain 2-3 = mild pain 4-6 = moderate pain 7-10 = severe pain pain recording will be done at 6 hrs , 24 hrs, 48hrs and 72 hrs. ( participants to be contacted by investigator at each point to check on them and remind them to record their pain ). The given questionnaire shall be collected when the participant comes for final restoration after 1 week	1 week

Collaborators and Investigators

• Sponsor: Armed Forces Institute of Dentistry, Pakistan
• Investigators: Principal Investigator: Hira Amjad, BDS, Armed Forces Institude Of Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2024
• Primary Completion (Estimated): May 7, 2025
• Study Completion (Estimated): May 8, 2025

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: January 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 19, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative
• Other Study ID Numbers: Cryotherapy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes