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Effectiveness of proteolytic enzymes in controlling the post operative sequelae of surgical third molar disimpactions

Prospective, Observer Blinded, Randomized Clinical Study to Evaluate the Effectiveness of Trypsin, Bromelain, Rutoside Fixed Dose Combination and Trypsin, Chymotrypsin Fixed Dose Combination on Post-Operative Pain, Swelling and Trismus following the Surgical Removal of an Impacted Mandibular Third Molar.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010076
Enrollment
75
Registered
2017-10-12
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- Partially or completely impacted mandibular third molars which need to be surgically extracted

Interventions

Intervention1: Cap Amoxicillin 500 mg Tab Diclofenac 50 mg Fixed dose combination of trypsin 48mg, bromelain 90mg, rutoside trihydrate 100 mg : Oral dose to be taken 3 times a day for 3 days [1 hour

Sponsors

Dr Chalakuzhy Paul Mathai
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients who need their partially or completely impacted mandibular third molars to be surgically extracted 2.Patients of any gender who fall in the age group of 18 to 60 years 3. Patients who do not show any active signs of infection

Exclusion criteria

Exclusion criteria: 1. Allergy to any of the drugs used in the study 2. Patients on anti-platelet or anti-coagulant therapy 3. Pregnant or lactating patients 4. Patients who have consumed any antibiotics or analgesics 1 week prior to the surgery 5. Patients who fall into ASA category 3 and above

Design outcomes

Primary

MeasureTime frame
Study changes between the 3 groups with respect to post operative 1. Pain [VAS from 1-10] 2. Swelling [measurements based on fixed extra oral anatomical landmarks] 3. Trismus [Inter-incisal mouth opening]Timepoint: The time points are as follows: 1st measurement is pre-operatively on Day 0. 2nd measurement is on Day 2 post-operatively. 3rd measurement is on Day 7 post-operatively.

Secondary

MeasureTime frame
N/ATimepoint: N/A

Countries

India

Contacts

Public ContactChalakuzhy Paul Mathai

Nair Hospital and Dental College

drnnandrade@yahoo.co.in9821126837

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026