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

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.

Study Overview

• Status: Completed
• Conditions: Impacted Mandibular Third Molar Extraction; Post Operative Swelling
• Intervention / Treatment: Device: Gelatin Sponge Sheet; Procedure: Swelling

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 46000
      • Watim Medical and Dental College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age 18-30 years old.
2. Either gender.
3. impacted third mandibular molar.
4. No history of periodontists
5. No bone recession on radiograph
6. Swelling at the side of impaction.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Gelatin Sponge; Swelling	Device: Gelatin Sponge Sheet; Gelatin sponge vs Suture Alone; Other Names: Suture; Sponge Stone; Procedure: Swelling; Suture
Other: Suture Alone; Swelling	Device: Gelatin Sponge Sheet; Gelatin sponge vs Suture Alone; Other Names: Suture; Sponge Stone; Procedure: Swelling; Suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Watim Medical & Dental College

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Actual): March 30, 2025
• Study Completion (Actual): March 30, 2025

Study Registration Dates

• First Submitted: November 28, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): December 29, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cell Physiological Phenomena; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices; Sutures; Mitochondrial Swelling
• Other Study ID Numbers: Ethical Review Board

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because want to avoid sharing their identity

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes