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Completed

NCT Number: NCT05866965

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.

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Key information

Conditions

Platelet-rich Fibrin

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Medicine and Pharmacy

Ho Chi Minh City, 700000, Vietnam

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

PRF

Other

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

standard third molar surgical removal

Other

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

Primary outcomes

  1. periodontal pocket depth

    Time frame: 1rst postoperative month

    periodontal pocket depth at distal buccal and distal lingual side of second molar

  2. periodontal pocket depth

    Time frame: 3rst postoperative month

    periodontal pocket depth at distal buccal and distal lingual side of second molar

  3. periodontal pocket depth

    Time frame: 6rst postoperative month

    periodontal pocket depth at distal buccal and distal lingual side of second molar

  4. distal bone resorption

    Time frame: 3rd postoperative month

    resorption of alveolar bone height distal to second molar

  5. distal bone resorption

    Time frame: 6th postoperative month

    resorption of alveolar bone height distal to second molar

Secondary outcomes

  1. soft tissue healing index

    Time frame: 3rd postoperative day

    soft tissue healing around third molar socket

  2. soft tissue healing index

    Time frame: 7th postoperative day

    soft tissue healing around third molar socket

Sponsors and collaborators

Lead sponsor

Lam Cu Phong

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 19, 2023
Registry last updated
May 19, 2023

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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