CTRI/2025/07/091406
Not yet recruiting
Phase 4
Comparative clinical evaluation of Postoperative Pain using 3% Cryotreated Hypochlorite and 0.9% Cryotreated Normal Saline against Conventional root canal treated groups in patients with Symptomatic Irreversible Pulpitis/ Apical Periodontitis after single visit root canal treatment: A Randomized Clinical Study
Dr Aditi Goel1 site in 1 country69 target enrollmentStarted: August 1, 2025Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Dr Aditi Goel
- Enrollment
- 69
- Locations
- 1
- Primary Endpoint
- Postoperative pain
Overview
Brief Summary
This study is single centre, double blinded study comparing the postoperative pain after single sitting root canal treatment using either 3% cryotreated Sodium hypochlorite(2°C–4°C) or 0.9% cryotreated normal saline(2°C–4°C) or 3% Sodium hypochlorite and 0.9% normal saline at room temperature along with passive ultrasonic irrigation in patients with symptomatic irreversible pulpitis / apical periodontitis. Clinical evaluation will be done based on postoperative pain after 6 hours, 24 hours , 48 hours and 72 hours using VRS scale.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 16.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy patient who will give informed consent will be included.
- •Single rooted teeth with completely matured root diagnosed with symptomatic irreversible pulpitis / apical periodontitis will be included.
- •Teeth with Peri Apical Index score 2 will be included in the study.
Exclusion Criteria
- •Teeth with immature roots, those diagnosed with pulp necrosis, cracks, internal/external root resorption or pulp canal obliteration and exhibiting clinical and/or radiographic signs of chronic/severe periodontitis or periapical abscess will be excluded.
- •Patients taking antibiotics, sedatives or analgesics before 24 hrs.
- •of treatment will be excluded.
- •Teeth with previously endodontic treatment will be excluded.
- •Patients with severe periodontitis and poor oral hygiene will be excluded from the study.
- •Pregnant or lactating women will be excluded.
Outcomes
Primary Outcomes
Postoperative pain
Time Frame: 6 hours , 24 hours , 48 hours , 72 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Aditi Goel
K.M Shah Dental College and Hospital
Study Sites (1)
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