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Study to Evaluate Pain Relief by Using Bupivacaine in Tooth Socket After Surgical Removal of Lower Wisdom Tooth

Evaluation of Efficacy of Intrasocket Local Application of Bupivacaine as Add on Pain Control Therapy in Patients Undergoing Surgical Extraction of Mandibular Third Molar: A Randomized Control Clinical Study. - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091857
Enrollment
120
Registered
2025-07-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K011- Impacted teeth

Interventions

Intervention1: Bupivacaine: After surgical extraction of mandibular 3rd molar a gel foam soaked in 2ml of 0.5% bupivacaine will be placed in socket once and sutures will be given. Pain will be checked

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Position B (according to Winters classification based on depth for impacted third molar) 2. Healthy patients of age 18 years and above of either gender requiring surgical extraction of impacted mandibular third molars. 3. Patients willing to participate in the study. 4. Anaesthesiologists physical classification level 1 (ASA-1)

Exclusion criteria

Exclusion criteria: 1. Patients with possible allergies or hypersensitivity to study drug and local anaesthesia and to drugs such as antibiotics and anti-inflammatory drugs. 2. Medically compromised patients such as cardiovascular disease, diabetes mellitus, hepatic disease, blood disorder, GI bleeding or ulceration. 3. Mentally challenged patients, pregnant women and Lactating mothers. 4. Patients on corticosteroid therapy. 5. Patients with reduced mouth opening due to conditions such as oral submucous fibrosis and hypoplastic mandible.

Design outcomes

Primary

MeasureTime frame
1. To determine the duration of pain relief obtained after locally administered Bupivacaine.Timepoint: Patients will be evaluated post administration of drug and to score the overall pain at 4hr, 6hr and 8hr using the VAS

Secondary

MeasureTime frame
To quantify the period of administration of an additional analgesic in the post operative period after locally administered Bupivacaine.Timepoint: Pain will be assessed at 4, 6 & 8 hours. Once the pain starts patients will be asked to take the analgesic drug after onset of pain & note the timing of medication.

Countries

India

Contacts

Public ContactDr Trupti Gandhewar

Nair Hospital Dental College

tgandhewar@yahoo.com9819323729

Outcome results

None listed

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