L-PRF vs PBM on Extraction Socket Healing

NCT06328413 | Completed FDA Device

• 1 other identifier: KAEK-302
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healing Surgical Wounds; Pain

Keywords

photobiomodulation; L-PRF; pain; bone healing; soft tissue healing; third molar

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Soft tissue healing

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

• Probing depth

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

Other Outcomes (1)

• Postoperative pain

  Postoperative 2nd, 4th and 7th days

Study Arms (2)

Photobiomodulation group

EXPERIMENTAL

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

Leukocyte and platelet-rich fibrin group

ACTIVE COMPARATOR

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

Interventions

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

Photobiomodulation group

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.

Leukocyte and platelet-rich fibrin group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University

Antalya, Merkez, 07058, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Low-Level Light Therapy; Leukocyte Count

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Cennet N Eroglu, DDS,PhD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Dr

Model Details: Since the groups were formed on the same individual, only which side would be the PBM and which side would be the L-PRF group was determined by coin-flip method (simple randomization).

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 25, 2024
• Study Start: April 20, 2020
• Primary Completion: June 21, 2021
• Study Completion: September 21, 2021
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)