A study comparing pain after root canal treatment using cold saline (cryotherapy) versus normal temperature saline in adults with painful tooth infection

A randomized controlled trial comparing the frequency of postoperative pain following intracanal cryotherapy versus room temperature saline irrigation in single-visit root canal treatment of teeth with symptomatic apical periodontitis

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12625000626460

Enrollment

146

Registered

2025-06-13

Start date

2025-08-19

Completion date

2026-02-25

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Study Title: Comparison of Postoperative Pain After Intracanal Cryotherapy vs. Room Temperature Saline in Single Visit Root Canal Therapy Study Purpose: This study aims to compare the frequency and severity of postoperative pain experienced by patients undergoing root canal therapy when treated with either intracanal cryotherapy or room temperature saline. The hypothesis is that cryotherapy will result in less postoperative pain compared to room temperature saline in patients with symptomatic apical periodontitis. Study Description: This clinical trial will involve patients who require root canal therapy for a painful dental condition known as symptomatic apical periodontitis. After the procedure, patients will be randomly assigned to receive either intracanal cryotherapy or room temperature saline as a treatment to manage pain. Participants will be followed up to assess pain levels at various timepoints following the procedure. Expected Outcome: The study will help determine which treatment option leads to less pain after root canal therapy, potentially improving patient comfort and treatment outcomes in endodontic care.

Interventions

Brief Name: Arm 1: Intracanal Cryotherapy (Cold Saline Irrigation) Arm 2: Room Temperature Saline Irrigation (Control) Arm 1 – Intracanal Cryotherapy • Description: Patients will receive final irrigation with 10 mL of cold (1.5°C–2.5°C) 0.9% normal saline delivered over 5 minutes. • Mode of Delivery: Irrigation to working length using a 30-gauge double-side vented needle. • Frequency & Duration: Single irrigation session during a single-visit root canal therapy. • Delivery Personnel: Performed by the principal investigator (FCPS II Endodontics resident) under supervision of a consultant endodontist. • Setting: Department of Operative Dentistry and Endodontics, Saidu College of Dentistry, Swat, Pakistan. • Support Activities: Syringes containing saline are pre-cooled in a digitally monitored refrigerator and retrieved immediately before use. • Personalization or Adaptation: Not applicable. • Intervention Fidelity: The procedure is standardized using defined volumes, time, and needle type; administered under supervision for consistency.

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

16 Years to 50 Years

Healthy volunteers

Inclusion criteria

1. Patients with ages ranging from 16 to 50 years. 2. Teeth indicated for single-visit root canal treatment after history, examination and radiographic findings of no periapical radiolucency and normal root anatomy. 3. Patients with good general health. (no medical history like diabetes mellitus and hypertension etc)

Exclusion criteria

1. History of allergy to local anesthetic agents or endodontic materials. 2. Presence of progressive periodontal disease after clinical and radiographic diagnosis like tooth mobility, deep pocketing associated with attachment loss and bone loss. 3. Nonrestorable tooth, or any signs of external and internal root resorption on a radiograph. 4. Retreatment cases diagnosed after clinical and radiographic examination. 5. Immature roots in radiographs due to unpredictable outcome.

Outcome results