To Compare the Efficacy Of Preoperative Use Of Enzyme & Anti-Oxidant Based Painkiller Over A Plain Painkiller On The Nerve Block And Postoperative Pain Control In Root Canal Treatment Of Infected Molars.

Comparative Efficacy Of Pre-Emptive Use Of Enzyme & Anti-Oxidant Based NSAID Over Plain NSAID On Inferior Alveolar Nerve Blockade And Postoperative Pain Control In Endodontic Treatment Of Molars With Symptomatic Pulpitis: A Randomized Controlled Clinical Trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/01/079023

Enrollment

Registered

2025-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: K044- Acute apical periodontitis of pulpal origin Health Condition 2: K040- Pulpitis

Interventions

Intervention1: Enzyme and Antioxidant based NSAID.: Composed of Bromelain 90mg, rutoside trihydrate 100mg, trypsin 48mg, diclofenac sodium 50mg to be given orally 60min before the endodontic treatment

Eligibility

Inclusion criteria

Inclusion criteria: 1. Mandibular molars diagnosed with Symptomatic Irreversible Pulpitis and Apical Periodontitis. 2. Had not taken any type of analgesic medication within the previous 12 h. 3. The absence of periapical radiolucency on radiographs, except for a widened periodontal ligament.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to diclofenac, bromelain, rutoside, trypsin, lidocaine or any other medication/ material used in study. 2. Diabetic, Hypertensive, Smoking, Pregnant or lactating women. 3. Any endocrine or infectious disease or had any systemic disease that contraindicate endodontic therapy. 4. Teeth with periodontal disease, necrotic tooth. 5. Radiographic images suggestive of internal or external resorptions. 6. Endodontic treatments not completed in a single session. 7. Failed to achieve adequate anesthesia (IANB).

Design outcomes

Primary

Measure	Time frame
To compare and evaluate the efficacy of the Enzyme and Antioxidant based NSAID as preoperative medication on the success of Inferior Alveolar Nerve Block. Timepoint: NRS pain scale scored from 0 to 10, taken 15 minutes after the Inferior Alveolar Nerve Block.	—

Secondary

Measure	Time frame
To compare and evaluate the influence of the Enzyme and Antioxidant based NSAID as preoperative medication on the intensity of pain during the procedure and postoperative pain at 4 intervals i.e. at 6, 12, 24 and 48 hours. Timepoint: NRS pain scale scored from 0 to 10 at 4 intervals i.e. at 6, 12, 24 and 48 hours.	—

Countries

India

Contacts

Public ContactDr S Srija Mili

MALLA REDDY DENTAL COLLEGE FOR WOMEN

drswathi.endo@gmail.com09866021672

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026