L-PRF vs PBM on Extraction Socket Healing

Comparative Evaluation of Pain, Soft Tissue Healing and Density of Newly Formed Bone Tissue in Surgical Extraction Sockets After Leukocyte and Platelet Rich Fibrin and Photobiomodulation Applications

The aim of this study is to compare leukocyte and platelet-rich fibrin (L-PRF) and photobiomodulation (PBM) applications, which have been repeatedly reported to be superior to control groups, in terms of pain, soft tissue and bone healing in tooth extraction sockets.

Study Overview

• Status: Completed
• Conditions: Pain; Healing Surgical Wounds
• Intervention / Treatment: Device: photobiomodulation; Other: Leukocyte and Platelet Rich Fibrin

Detailed Description

After sample size calculation, healthy volunteers were included in the study. Both teeth of these individuals with bilaterally impacted wisdom teeth were extracted simultaneously. Photobiomodulation (PBM) or leukocyte and platelet rich fibrin (L-PRF), an autogenous blood product, was randomly applied to the right or left side extraction sockets. Volunteers were called for repeat sessions (days 2,4,7,7,11,11,14,18 and 21) for the PBM treated side. Follow-ups were performed for pain (days 2,4,7) and soft and bone tissue healing.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Antalya, Merkez, Turkey, 07058
      • Akdeniz University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) Class-I healthy volunteers
• Between 18 and 40 years of age who had wisdom teeth (Pell and Gregory Class II, Position B) with bone retention in bilateral symmetrical position with an indication for extraction, and had second molars in the mouth,
• Not use steroids or anti-inflammatory drugs in the last 3 months.

Exclusion Criteria:

• Patients with pericoronitis,
• Smoking habits
• Active periodontal disease
• Pregnancy,
• Breastfeeding
• Unable to give personal consent, and those with missing physical examination and follow-up records were excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation group; Photobiomodulation application at different extra and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar	Device: photobiomodulation; Photobiomodulation application at different extraoral and intraoral points for 60 seconds with a wavelength of 940 nm in repeated sessions after the extraction of third molar
Active Comparator: Leukocyte and platelet-rich fibrin group; Leukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session.	Other: Leukocyte and Platelet Rich Fibrin; Leukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Newly formed bone (Healing at extraction sockets)	Newly formed bone assessed on Panoramic x-ray with Image J programme	Bone healing at the end of 1st and 3rd months after third molar extractions

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue healing	Landry Index scores (1: Very poor, 2: Poor, 3: Good, 4. Very Good, 5. Excellent healing)	End of 1st, 2nd week and 1st month after tooth extraction
Probing depth	Probing depth of second mandibular molar distal pocket (millimeters)	End of 1st, 2nd week and 1st month after tooth extraction

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Visual Analogue Scale (0=no pain, 10=unbearable pain)	Postoperative 2nd, 4th and 7th days

Collaborators and Investigators

• Sponsor: Akdeniz University
• Investigators: Principal Investigator: Cennet N Eroglu, DDS,PhD, Akdeniz University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2020
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2024
• Last Update Submitted That Met QC Criteria: March 21, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: pain; bone healing; third molar; photobiomodulation; L-PRF; soft tissue healing
• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: KAEK-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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