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Completed

NCT Number: NCT06328413

L-PRF vs PBM on Extraction Socket Healing

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.

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Key information

Conditions

Healing Surgical Wounds Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Akdeniz University

Antalya, Merkez, 07058, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Photobiomodulation

Device

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

Leukocyte and Platelet Rich Fibrin

Other

Leukocyte and platelet rich fibrin ( blood product centrifuged for 12 minutes at 2700rpm) application after third molar extraction, single session.

Primary outcomes

  1. Newly formed bone (Healing at extraction sockets)

    Time frame: Bone healing at the end of 1st and 3rd months after third molar extractions

    Newly formed bone assessed on Panoramic x-ray with Image J programme

Secondary outcomes

  1. Soft tissue healing

    Time frame: End of 1st, 2nd week and 1st month after tooth extraction

    Landry Index scores (1: Very poor, 2: Poor, 3: Good, 4. Very Good, 5. Excellent healing)

  2. Probing depth

    Time frame: End of 1st, 2nd week and 1st month after tooth extraction

    Probing depth of second mandibular molar distal pocket (millimeters)

Other outcomes

  1. Postoperative pain

    Time frame: Postoperative 2nd, 4th and 7th days

    Visual Analogue Scale (0=no pain, 10=unbearable pain)

Sponsors and collaborators

Lead sponsor

Akdeniz University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 25, 2024
Registry last updated
Mar 25, 2024

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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