Comparative usefulness of self-applied cold-pack therapy versus oral Serratiopeptidase after surgical removal of lower wisdom teeth.

Comparative efficacy of self-applied cold-pack therapy versus oral Serratiopeptidase in reduction of swelling, pain and trismus associated with surgical extraction of mandibular third molars: A randomized controlled trial.

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/12/022522

Enrollment

105

Registered

2019-12-26

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: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

Intervention1: Oral Serratiopeptidase with usual care: Serratiopeptidase 15mg tablet bd for 3 days Intervention2: Cold pack with usual care: Self-applied cold pack through site to be used intermittent

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients visiting Manav Rachna Dental College OPD at Department of Oral and Maxillofacial Surgery indicated for surgical extraction of mandibular third molar. 2. Provision of signed and dated informed consent form 3. Patients aged 18 to 40 years 4. In good general health as evidenced by medical history. 5. Diagnosed with distoangular or horizontal impacted mandibular third molar tooth evidenced through OPG radiograph. 6. Willingness to adhere to the study intervention regimen.

Exclusion criteria

Exclusion criteria: 1. Current use of analgesics and antibiotics for systemic disease that alters the pain and swelling process. 2. Presence of any systemic disease through medical history 3. Pregnancy and lactation. 4. Known allergic reactions to components of cold/ ice packs or drugs used in the study. 5. Febrile illness. 6. Treatment with another investigational drug or other intervention. 7. History of use of tobacco in any form.

Design outcomes

Primary

Measure	Time frame
Distance between tragus and commissure of lip on same side. Change in distance between outer canthus of eye and angle of mandible. Change in distance between two vernier calliper points measured from the lingual aspect of the mid-portion of the crown of the mandibular 1st molar (on the same side) to the tangent of the skin of the cheek. Timepoint: Baseline 24 hours post operative 7 days post operative	—

Measure

Time frame

Distance between tragus and commissure of lip on same side. Change in distance between outer canthus of eye and angle of mandible. Change in distance between two vernier calliper points measured from the lingual aspect of the mid-portion of the crown of the mandibular 1st molar (on the same side) to the tangent of the skin of the cheek. Timepoint: Baseline 24 hours post operative 7 days post operative

—

Secondary

Measure	Time frame
Secondary Endpoints: â?¢ Change in mean Visual Analogue Scale for pain Timepoint: Every 4 hours during waking hours and any time if patient has to wake up from sleep due to pain.	—

Countries

India

Contacts

Public ContactAnkur Sharma

Manav Rachna Dental COllege

ankur.pubheal@gmail.com9560299027

Outcome results

None listed

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