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

NCT05866965 | Completed

• 1 other identifier: lamphongrhm
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Platelet-rich Fibrin

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• soft tissue healing index

  3rd postoperative day

• soft tissue healing index

  7th postoperative day

Study Arms (2)

control

ACTIVE COMPARATOR

standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy

Other: standard third molar surgical removal

PRF

EXPERIMENTAL

PRF was applied in third molar socket after removal following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy

Other: PRF

Interventions

PRF OTHER

centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin

PRF

standard third molar surgical removal OTHER

standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy

control

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lam Cu Phong: lead

Study Sites (1)

University of Medicine and Pharmacy

Ho Chi Minh City, 700000, Vietnam

Location

Study Officials

• Phong Cu Lam, Master

  University of Medicine and Pharmacy, Ho Chi Minh city

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: split-mouth study, 1 side would be the study side and other side would be control side

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 19, 2023
• Study Start: December 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 19, 2023

Record last verified: 2023-05

Locations

VN (1)