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OpenTrials
Completed

NCT Number: NCT07153133

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

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.

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Key information

Conditions

Tooth Extraction Site Healing

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Mansoura Universty

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

Other names: Alb-PRF

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.

Primary outcomes

  1. Assessment of Facial Swelling (Edema): in Centimeters

    Time frame: first day, third day and seventh day

    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

  2. Wound Healing: Disturbed/Not Disturbed

    Time frame: first day, third day and seventh day

    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

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

    Time frame: first day, third day and seventh day

    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.

  4. Laboratory Assessments of multiple blood/Biochemical markers and their concentrations

    Time frame: first day, third day and seventh day

    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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Efficacy of Albumin Platelet Rich Fibrin on Complications After Mandibular Third Molar Extraction: A Clinical and Biochemical Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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