L-PRF vs PBM on Extraction Socket Healing

Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06328413
• Other study ID #: KAEK-302
• Status: Completed
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: September 21, 2021

Study information

• Verified date: March 2024
• Source: Akdeniz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healing Surgical Wounds
• Pain
• Surgical Wound

Intervention

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

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.

Locations

Country	Name	City	State
Turkey	Akdeniz University	Antalya	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Akdeniz University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Postoperative pain	Visual Analogue Scale (0=no pain, 10=unbearable pain)	Postoperative 2nd, 4th and 7th days
Primary	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	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
Secondary	Probing depth	Probing depth of second mandibular molar distal pocket (millimeters)	End of 1st, 2nd week and 1st month after tooth extraction