Evaluation of Trypsin-Chymotrypsin and Ibuprofen versus Ibuprofen alone for Pain Relief after Root Canal Treatment: A Randomized Study.

Effect of preoperative oral administration of trypsin- chymotrypsin + Ibuprofen in comparison to Ibuprofen on postoperative pain following single- visit root canal treatment -A parallel arm randomized control trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108200

Enrollment

Registered

2026-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: K045- Chronic apical periodontitis Health Condition 2: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: trypsin-chymotrypsin+Ibuprofen: The respective drug inside the sealed envelope trypsin-chymotrypsin (1,00,000 AU) will be administered orally 1 hour before surgery only once + Ibuprofen

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 65 years, male or female. 2. Patients requiring primary single-visit root canal treatment in mandibular first molar teeth. 3. Teeth diagnosed with symptomatic irreversible pulpitis, symptomatic apical periodontitis, or normal periapical tissues requiring RCT. 4. Patients classified as ASA Physical Status I or II (medically healthy or mild systemic conditions). 5. Ability to understand the study protocol, provide written informed consent, and comply with postoperative pain assessments (VAS diaries and follow-up). 6. No analgesics or anti-inflammatory medications taken within 12 hours prior to treatment. 7. Teeth with restorable structure and normal periodontal support.

Exclusion criteria

Exclusion criteria: 1. Known hypersensitivity or contraindication to trypsin chymotrypsin, NSAIDs, ibuprofen, or excipients used in the capsules. 2. History of gastrointestinal ulcers, bleeding disorders, or chronic NSAID-induced GI issues. 3. Significant renal, hepatic, or cardiovascular disease. 4. Current use of anticoagulants, corticosteroids, immunosuppressants, or proteolytic enzyme supplements. 5. Pregnant or lactating women, or those planning pregnancy during the study. 6. Systemic infections or chronic inflammatory disorders. 7. Teeth diagnosed with asymptomatic irreversible pulpitis

Design outcomes

Primary

Measure	Time frame
Post-operative pain intensity measured using VAS scoreTimepoint: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours	—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Piyush Oswal

Dr D Y Patil dental college and hospital Pimpri Pune

dr.piyushoswal8@gmail.com9422790865

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026