THE COMPARISON OF GELATIN SPONGE TO SUTURE ALONE ON POST OPERATIVE SWELLING AFTER EXTRACTION OF IMPACTED MANDIBULAR THIRD MOLAR.

NCT07306403 | Completed FDA Device

• 1 other identifier: Ethical Review Board
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This Study is designed for purpose to increase patient safety and reduce complications which occurs after mandibular 3rd molar extraction which is will increase discomfort after extraction. My study hypothesis is that gelatin sponge after extraction reduce swelling post extraction wisdom tooth.For understanding when we remove wisdom tooth, we involve hard and soft tissiues which will result in post extraction swelling.

Conditions

Post Operative Swelling; Impacted Mandibular Third Molar Extraction

Outcome Measures

Primary Outcomes (1)

• Post Extraction Swelling

  Measurements will be taken from angle of mandible to commissure of lips by measuring tape by Amin and Laskin Method.

  Pre extraction, 1st day post extraction, 3rd day post extraction and 7th day post extraction.

Study Arms (2)

Gelatin Sponge

OTHER

Swelling

Device: Gelatin Sponge Sheet; Procedure: Swelling

Suture Alone

OTHER

Swelling

Device: Gelatin Sponge Sheet; Procedure: Swelling

Interventions

Gelatin Sponge Sheet DEVICE

Gelatin sponge vs Suture Alone

Also known as: Sponge Stone, Suture

Gelatin Sponge; Suture Alone

Swelling PROCEDURE

Suture

Gelatin Sponge; Suture Alone

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-30 years old.
• Either gender.
• impacted third mandibular molar.
• No history of periodontists
• No bone recession on radiograph
• Swelling at the side of impaction.

You may not qualify if:

• Patients with ASA status lll and above.
• Patients requiring multiple extractions in same appointment.
• Patients allergic to Lignocaine.
• Patients in whom adrenaline is contraindicated.
• Medically compromised individual such as those with poorly controlled diabetes, hypertension and pregnancy,

Sponsors & Collaborators

• Watim Medical & Dental College: lead

Study Sites (1)

Watim Medical and Dental College

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Interventions

Sutures; Mitochondrial Swelling

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies; Cell Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Comparison of Gelatin Sponge To Suture Alone on Post Operative Swelling After Extraction of Impacted Mandibular Third Molar

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 29, 2025
• Study Start: August 30, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)