Skip to content

a clinical study to determine efficacy of proteolytic enzymes in dental surgery

A prospective, double blind, randomized study evaluating the efficacy of systemically administered combination of proteolytic enzymes in third molar surgery: A clinical study.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012502
Enrollment
200
Registered
2018-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients Requiring Surgical Removal of impacted third molar Under Local Anesthesia on an out patient basis will be included in the trial

Interventions

Intervention1: Fixed Dose Combination of Trypsin , Bromelain and Rutoside: Trypsin â?? 48mg Bromelain â?? 90mg Rutoside â?? 100 mg Regimen: one hour before meals every 8 hours or thrice a day Control

Sponsors

Nair Hospital Dental College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Any patient with an partially impacted mandibular third molars (upto Level B, as per the Pell and Gregory scales) and indicated for its surgical extraction. 2. Any patient who willingly gives consent for the being involved in the study 3. Healthy adult patients in the age group of 18-40 years.

Exclusion criteria

Exclusion criteria: 1. Pregnant females and Lactating mothers. 2. Patients who had/have any periapical or odontogenic lesion associated with the impacted tooth. 3. Patient known to be allergic to any constituent of the proteolytic drug combination. 4. Patients with a known allergy to co-amoxiclav group or NSAID drugs. 5. Patients with any underlying systemic condition/medication which will interfere with drug metabolism. 6. Patients on immunosuppresants. 7. Interincisal opening less than 3 cms.

Design outcomes

Primary

MeasureTime frame
Pain - VAS Score(Visual Analog Scale) Swelling- Analytical assessment using Facial MeasurementsTimepoint: Day 0, Postoperative Day 1, Day 5 and Day 7

Secondary

MeasureTime frame
Mouth Opening, Day of Work Attendance, Day of Resuming Eating, Number of Rescue Medications needed, Overall DiscomfortTimepoint: Pre op Day 0, Post op Day 1, Day 5 and Day 7

Countries

India

Contacts

Public ContactTrupti Gandhewar

Nair Hospital Dental College

tgandhewar@yahoo.com9819323729

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 26, 2026