Ultrasonic Activated Irrigation and Intracanal Cryotherapy for Reducing Pain After Root Canal Treatment

NCT07663227 | Not Yet Recruiting

• 1 other identifier: GU/Ethical Committee/2025/248
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled trial aims to evaluate the effect of ultrasonic activated irrigation with and without intracanal cryotherapy on postoperative pain following single-visit root canal treatment in teeth with symptomatic irreversible pulpitis. Participants requiring root canal treatment will be randomly allocated into two groups. One group will receive ultrasonic activated irrigation alone, while the other group will receive ultrasonic activated irrigation followed by intracanal cryotherapy. Postoperative pain will be assessed at predetermined time intervals using a standardized pain assessment scale. The findings of this study may help identify effective strategies for reducing postoperative pain after root canal treatment and improving patient comfort and treatment outcomes.

Conditions

Symptomatic Irreversible Pulpitis and Post Operative Pain

Keywords

Symptomatic irreversible pulpitis; Intracanal Cryotherapy; Ultrasonic Activated Irrigation; Postoperative Pain; Single-visit Root Canal Treatment

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Postoperative pain intensity will be assessed using a 10-point Visual Analogue Scale (VAS). Pain scores will be recorded through telephone follow-up at 12, 24, 48, and 72 hours after completion of single-visit root canal treatment.

  12,24,48 and 72 hours after the completion of single-visit root canal treatment

Study Arms (2)

Ultrasonic Activated Irrigation Without Intracanal Cryorherapy

ACTIVE COMPARATOR

Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of room-temperature 0.9% saline will be delivered over 5 minutes. The canals will then be obturated and permanently restored in the same visit.

Procedure: Ultrasonic Activated Irrigation

Ultrasonic Activated Irrigation With Intracanal Cryotherapy

EXPERIMENTAL

Participants assigned to this arm will undergo single-visit root canal treatment under local anesthesia and rubber dam isolation. Root canal preparation will be performed using the ProTaper Universal rotary system. Irrigation during instrumentation will be carried out using 5.25% sodium hypochlorite with ultrasonic activation for one minute per canal. At the final irrigation stage, 10 mL of cold (1.5-2.5°C) 0.9% saline will be delivered 1 mm short of the working length over 5 minutes as intracanal cryotherapy. The canals will then be obturated and permanently restored in the same visit.

Procedure: Ultrasonic Activated Irrigation; Procedure: Intracanal cryotherapy

Interventions

Ultrasonic Activated Irrigation PROCEDURE

Ultrasonic activation of 5.25% sodium hypochlorite was performed for one minute per canal, 1 mm short of the working length, during single-visit root canal treatment to enhance irrigant penetration and canal debridement.

Ultrasonic Activated Irrigation With Intracanal Cryotherapy; Ultrasonic Activated Irrigation Without Intracanal Cryorherapy

Intracanal cryotherapy PROCEDURE

Intracanal cryotherapy was performed by delivering 10 mL of cold 0.9% saline (1.5-2.5°C) passively 1 mm short of the working length over 5 minutes as the final irrigation step during single-visit root canal treatment.

Ultrasonic Activated Irrigation With Intracanal Cryotherapy

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Patients who are medically fit (ASA Physical Status I) and aged between 20 and 50 years will be recruited for the study.
• \. Mandibular first or second molars exhibiting signs of symptomatic irreversible pulpitis, identified through an extended sensitivity to cold testing and/or a positive electric pulp test.
• Vital pulp with no signs of apical pathology (normal periapical radiograph, no swelling, sinus tract, or mobility).
• \. Mature roots with closed apices and no prior root canal treatment. 5. Willing to undergo single-visit treatment and comply with follow-up.

You may not qualify if:

• Use of analgesics or NSAIDs within 12 hours prior to treatment. 2.Pregnant or lactating women. 3.Presence of systemic illness or allergy to any materials used in the study. 4.Teeth with:
• Non-vital pulp, periapical radiolucency, or sinus tract.
• Mobility \> Grade I or periodontal pockets \> 5 mm.
• Resorption, calcification, or non-restorable crown structure. 5.Third molars (wisdom teeth). 6.Endodontically treated tooth. 7.Inability or unwillingness to follow study instructions or complete follow-up.

Sponsors & Collaborators

• Dr Arsalan Ali Khan: lead

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

• Shakeel Ur Rehman Khattak, BDS,BSc,MHR,FCPS

  Sardar Begum Dental College,Gandhara University,Peshawar,Pakitstan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: FCPS Resident in Operative Dentistry and Endodontics

Model Details: Participants with symptomatic irreversible pulpitis in mandibular first or second molars will be randomly allocated into two parallel groups. Group A will receive ultrasonic activated irrigation without intracanal cryotherapy, while Group B will receive ultrasonic activated irrigation followed by intracanal cryotherapy using 0.9% saline at 1.5-2.5°C for 5 minutes. All root canal treatments will be completed in a single visit, and postoperative pain will be assessed at 12, 24, 48, and 72 hours using a Visual Analogue Scale (VAS).

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share