Effectiveness of Cryotherapy on Endodontic Pain

NCT06785753 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Cryotherapy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

normal saline group

EXPERIMENTAL

In control group , canals will be irrigated with 5ml of normal saline at room temperature

Drug: Irrigation Solution

cryotherapy (cold saline group)

EXPERIMENTAL

in cold saline group , canals will be irrigated with 5 ml of cold saline at a temperature of 2.5° C

Drug: Irrigation Solution

Interventions

Irrigation Solution DRUG

normal saline will be used as irrigation solution

Also known as: normal saline irrigant

cryotherapy (cold saline group); normal saline group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Armed Forces Institute of Dentistry, Pakistan: lead

Study Sites (1)

Armed Forces Institute of Dentistry

Rawalpindi, Punjab Province, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hira Amjad, BDS

  Armed Forces Institude Of Dentistry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hira Amjad, BDS

CONTACT

03345294071; anmolamjad03@gmail.com

Kanza Zafar, BDS

CONTACT

03337808809; kanzazafar6@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Hira Amjad , Principal investigator and Resident Operative Dentistry and Endodontics

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: January 21, 2025
• Study Start: November 7, 2024
• Primary Completion: May 7, 2025
• Study Completion: May 8, 2025
• Last Updated: January 21, 2025

Record last verified: 2024-06

Locations

PA (1)