Efficacy of Albumin Platelet Rich Fibrin on Complications After Mandibular Third Molar Extraction.

NCT07153133 | Completed

• 1 other identifier: Ms.25.03.5
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Sixteen patients with bilateral impacted lower third molars seeking treatment will be recruited from the out-patient clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry at Mansoura University.

Conditions

Tooth Extraction Site Healing

Outcome Measures

Primary Outcomes (4)

• Assessment of Facial Swelling (Edema): in Centimeters

  Measurements will be taken before surgery (baseline). Swelling will be evaluated by comparing the difference between preoperative and postoperative measurements. Swelling will be evaluated in Centimeters using a tape measure. Performed on the patient's operated site using these reference points: * A) Lateral corner of the eye/angle of the mandible * B) Tragus/outer corner of the mouth * C) Tragus/soft tissue pogonion

  first day, third day and seventh day

• Wound Healing: Disturbed/Not Disturbed

  The area of operation will be examined for Any manifestations of wound healing disturbance including: * Swelling, redness, hotness, pus discharge, signs and symptoms of infection, Wound dehiscence * Exposure of underlying hard tissue will be carefully noted

  first day, third day and seventh day

• Postoperative pain severity assessment : using a 10 point Visual Analogue Scale (VAS)

  Pain will be evaluated using Visual Analogue Scale (VAS). Which is a 10 point scale, in which the minimum end '0" represents no pain, while the maximum end 10" represents the worst pain.

  first day, third day and seventh day

• Laboratory Assessments of multiple blood/Biochemical markers and their concentrations

  First 5 cm of blood will be withdrawn under aseptic conditions using sterile venipuncture, then blood will be separated immediately by centrifugation (3000 rpm). To be assessed using enzyme-linked immunosorbent assays (ELISA) kits according to the manufacturer's protocol for their Serum concentrations of: interleukin 6, macrophage inflammatory protein, granulocyte macrophage colony-stimulation factor, and vascular endothelial growth factor

  first day, third day and seventh day

Study Arms (2)

Control: No Autologous Albumin Gel applied Side

ACTIVE COMPARATOR

Surgical extraction of impacted third molar without autologous albumin gel application.

Procedure: Surgical extraction of impacted third molar

Study: Autologous Albumin Gel applied Side

EXPERIMENTAL

Surgical extraction of impacted third molar with autologous albumin gel application.

Device: Alb-PRF Autologous Albumin Gel

Interventions

Alb-PRF Autologous Albumin Gel DEVICE

Socket curettage and bone filing will be done using a bone curette and bone file, respectively. Extraction sockets with albumin gel application. 0.2 ml of autologous albumin gel will be applied to all four edges of the extraction socket

Also known as: Alb-PRF

Study: Autologous Albumin Gel applied Side

Surgical extraction of impacted third molar PROCEDURE

Socket curettage and bone filing will be done using a bone curette and bone file, respectively. Extraction sockets will be left without autologous albumin gel application.

Control: No Autologous Albumin Gel applied Side

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy patients classified as ASA (American Society of Anesthesiologists) Physical Status Classification Class I.
• Patients seeking extraction of both mandibular third molars.
• Patients aged 18 - 40 years old by the day of surgery.
• Patients willing to participate in the study and commit to regular follow-up appointments.

You may not qualify if:

• Heavy Smokers (more than 25 cigarettes per day).
• Patients with Poor oral hygiene.
• Patients with history of a chemotherapy or radiotherapy

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura Universty

Al Mansurah, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Demonstrator at oral and maxillofacial surgery department, Faculty of dentistry, Mansoura University, Mansoura University

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: September 20, 2025
• Primary Completion: February 25, 2026
• Study Completion: March 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2025-08

Locations

EG (1)