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

Platelet-rich Fibrin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05866965
• Other study ID #: lamphongrhm
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontal Pocket
• Platelet-rich Fibrin

Intervention

Other:
• PRF
centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin
• standard third molar surgical removal
standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy

Locations

Country	Name	City	State
Vietnam	University of Medicine and Pharmacy	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Lam Cu Phong

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	periodontal pocket depth	periodontal pocket depth at distal buccal and distal lingual side of second molar	1rst postoperative month
Primary	periodontal pocket depth	periodontal pocket depth at distal buccal and distal lingual side of second molar	3rst postoperative month
Primary	periodontal pocket depth	periodontal pocket depth at distal buccal and distal lingual side of second molar	6rst postoperative month
Primary	distal bone resorption	resorption of alveolar bone height distal to second molar	3rd postoperative month
Primary	distal bone resorption	resorption of alveolar bone height distal to second molar	6th postoperative month
Secondary	soft tissue healing index	soft tissue healing around third molar socket	3rd postoperative day
Secondary	soft tissue healing index	soft tissue healing around third molar socket	7th postoperative day