Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery

A Randomized, controlled clinical trial and split-mouth design was performed to assess and compare the effect of platelet-rich fibrin (PRF) on soft tissue healing, periodontal pocket depth and alveolar bone height distal to second molar of the study and control groups after third molar surgical removal.

Sample include of participants who had indication of impacted lower third molars extraction on both sides with symmetrically orientation and same difficult index. All participants had same extraction protocol on both side at Department of Oral surgery, Faculty of Odonto-stomatology, University of Medicine and Pharmacy, Ho Chi Minh City.

Soft tissue healing, periodontal pocket depth and distal bone height were evaluation by an independent investigator.

Study Overview

• Status: Completed
• Conditions: Platelet-rich Fibrin
• Intervention / Treatment: Other: standard third molar surgical removal; Other: PRF

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • University of Medicine and Pharmacy

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patient over 18 years old.
• Good general health.
• Bilateral lower third molars equivalent in inclination and Pell and Gregory's impaction classification (classification II, III and B, C). The assessment of equivalence between two mandibular third molars was determined on the panoramic radiograph.
• The difference of third molar inclination on both sides not greater than 15 degrees.
• The patient consented to participate in the study after hearing clearly the explanation of purposes and requirements of the study.

Exclusion Criteria:

• Patients with any systemic disease contraindicated for surgery.
• Presence of acute inflammation or infection at third molar areas.
• Patients refused to participate in the study, did not comply with treatment or did not come to the follow-up examination as required.
• The difference in surgical time between the two groups was more than 10 minutes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control; standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy	Other: standard third molar surgical removal; standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
Experimental: PRF; PRF was applied in third molar socket after removal following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy	Other: PRF; centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
periodontal pocket depth	periodontal pocket depth at distal buccal and distal lingual side of second molar	1rst postoperative month
periodontal pocket depth	periodontal pocket depth at distal buccal and distal lingual side of second molar	3rst postoperative month
periodontal pocket depth	periodontal pocket depth at distal buccal and distal lingual side of second molar	6rst postoperative month
distal bone resorption	resorption of alveolar bone height distal to second molar	3rd postoperative month
distal bone resorption	resorption of alveolar bone height distal to second molar	6th postoperative month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
soft tissue healing index	soft tissue healing around third molar socket	3rd postoperative day
soft tissue healing index	soft tissue healing around third molar socket	7th postoperative day

Collaborators and Investigators

• Sponsor: Lam Cu Phong
• Investigators: Principal Investigator: Phong Cu Lam, Master, University of Medicine and Pharmacy, Ho Chi Minh city

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: lamphongrhm

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No