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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05866965
Other study ID # lamphongrhm
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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