Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit RCT

NCT07598188 | Not Yet Recruiting DMC

• 1 other identifier: IslamabadDentalHospital(IDH)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 60 patients presenting with single-rooted teeth exhibiting symptomatic apical periodontitis were subjected to a randomized allocation into two groups of 30 each. Irrigation was done using 3% sodium hypochlorite for 5 seconds in all 60 teeth. Group 1 underwent final irrigation utilizing normal saline at room temperature. Group 2 received final irrigation using normal saline refrigerated between 2-5°C. Pain levels were assessed and recorded before the procedure and at 24 and 48-hour time intervals.

Conditions

Periapical Diseases

Keywords

Cold therapy, Saline solution, periapical diseases, sodium hypochlorite

Outcome Measures

Primary Outcomes (1)

• To evaluate the reduction of postoperative pain

  Patients will be instructed to record their pain score on VAS at 24 and 48 h. and will be asked to contact and visit in case they experience severe pain. If visit is not possible,a telephonic feedback will be recorded and assistance will be guided

  24-48 hours

Study Arms (2)

Intervention Group

EXPERIMENTAL

In the cryotherapy group, following completion of biomechanical preparation, the root canals will be irrigated with 20ml of 0.9% physiological saline solution at a temperature of 1.5-2.5°C for 5 min

Drug: Saline 0.9% (1.5-2.5°C)

Control Group

NO INTERVENTION

In the control group, final irrigation will be performed using 20 mL of 0.9% physiological saline solution at room temperature for 5 min

Interventions

Saline 0.9% (1.5-2.5°C) DRUG

In this study participant are suing 0.9% normal saline but the temperature will be different for both groups .In cryotherapy group participant are using saline at cold temperature1.5-2.5°C

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individual (male/female) with age \>18 years with symptomatic apical periodontitis in permanent teeth

You may not qualify if:

• Teeth with calcified canals or aberrant root anatomy,
• Female Pregnant patients
• Patients using medications such as analgesics or anti-biotics drugs and
• Those who refuse to participate in the study

Sponsors & Collaborators

• Islamabad Medical and Dental College: lead

Study Sites (1)

Islamabad Dental Hospital

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Periapical Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Aroosa Bakhtawar, BDS

CONTACT

03379248459; bakhtawararoosa@gmail.com

Saima Azam, BDS, FCPS

CONTACT

00923005350740; saima.azam@iideas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)