The Clinical Impact of E-PRF and H-PRF on Healing After Mandibular Third Molar Surgery

Amila Haskic

Status and phase: Completed; Phase 3

Conditions: Platelet-Rich Fibrin

Treatments: Biological: H-PRF (Horizontal-platelet rich fibrin); Biological: E-PRF

Study type: Interventional

Funder types: Other

Identifiers

NCT05772975

02-3-4-59-1-3/2021

Details and patient eligibility

About

This clinical trial aims to compare the effect of platelet concentrates E-PRF and H-PRF on soft and hard tissue healing in healthy individuals after lower third molar surgery. The main questions it aims to answer are:

Do E-PRF and H-PRF reduce complications after third molar surgery? Do E-PRF and H-PRF improve soft tissue healing after third molar surgery? Do E-PRF and H-PRF improve hard tissue healing after third molar surgery? Participants will be divided into 2 study groups and one control group. Third molar surgery will be performed according to standard protocol. In study groups, dentoalveolar defects will be filled with E-PRF and H-PRF which are products of centrifugation of the patient's blood without additives. Soft tissue and hard tissue healing will be compared between the groups.

Full description

A Randomized, Three Parallel Arms Clinical Trial. The primary objective is to assess the clinical impact of E-PRF vs H-PRF vs Control on the soft tissue healing and post-op discomfort and complications after mandibular third molar surgery between the three groups during the healing period of 7 days.

The secondary objective is to compare bony healing between the three groups over three months using an Orthopantomograph (OPG) X-ray.

All subjects from the University of Sarajevo Faculty of Dentistry with Dental Clinical Center. Subjects that are coming for the removal of impacted mandibular third molars and match the inclusion criteria will be told about the research and offered the opportunity to participate.

Enrollment: 61 patients

Sex: All

Ages: 16 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Orthodontic indication for impacted mandibular third molar surgery
• Physical status I according to the guidelines of the American Society of Anesthesiologists (ASA)

Exclusion criteria

• Presence of systemic disease
• Presence of a condition that affects fibrin clot formation
• History of radiation therapy or chemotherapy
• Allergy to penicillin
• Oral contraceptive usage
• Smoking habit
• Status of pregnancy or lactation
• Presence of any acute local infection
• Missing the adjacent second molar or indicated for extraction

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 3 patient groups

E-PRF

Experimental group

Description:

After the impacted mandibular third molar has been surgically removed E-PRF is placed in the dentoalveolar defect and the wound is primarily closed.

Treatment:

Biological: E-PRF

H-PRF

Experimental group

Description:

After the impacted mandibular third molar has been surgically removed H-PRF is placed in the dentoalveolar defect PRF made with horizontal centrifuge and the wound is primarily closed.

Treatment:

Biological: H-PRF (Horizontal-platelet rich fibrin)

CONTROL

No Intervention group

Description:

After the impacted mandibular third molar has been surgically removed, the wound is primarily closed.