Back to resultsEffect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
Primary Purpose
Platelet-rich Fibrin
Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
PRF
standard third molar surgical removal
Sponsored by
About this trial
This is an interventional supportive care trial for Platelet-rich Fibrin
Eligibility Criteria
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.
Sites / Locations
- University of Medicine and Pharmacy
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control
PRF
Arm Description
standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
PRF was applied in third molar socket after removal following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
Outcomes
Primary Outcome Measures
periodontal pocket depth
periodontal pocket depth at distal buccal and distal lingual side of second molar
periodontal pocket depth
periodontal pocket depth at distal buccal and distal lingual side of second molar
periodontal pocket depth
periodontal pocket depth at distal buccal and distal lingual side of second molar
distal bone resorption
resorption of alveolar bone height distal to second molar
distal bone resorption
resorption of alveolar bone height distal to second molar
Secondary Outcome Measures
soft tissue healing index
soft tissue healing around third molar socket
soft tissue healing index
soft tissue healing around third molar socket
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05866965
Brief Title
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
Official Title
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lam Cu Phong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet-rich Fibrin
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
split-mouth study, 1 side would be the study side and other side would be control side
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Active Comparator
Arm Description
standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
Arm Title
PRF
Arm Type
Experimental
Arm Description
PRF was applied in third molar socket after removal following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
Intervention Type
Other
Intervention Name(s)
PRF
Intervention Description
centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin
Intervention Type
Other
Intervention Name(s)
standard third molar surgical removal
Intervention Description
standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
Primary Outcome Measure Information:
Title
periodontal pocket depth
Description
periodontal pocket depth at distal buccal and distal lingual side of second molar
Time Frame
1rst postoperative month
Title
periodontal pocket depth
Description
periodontal pocket depth at distal buccal and distal lingual side of second molar
Time Frame
3rst postoperative month
Title
periodontal pocket depth
Description
periodontal pocket depth at distal buccal and distal lingual side of second molar
Time Frame
6rst postoperative month
Title
distal bone resorption
Description
resorption of alveolar bone height distal to second molar
Time Frame
3rd postoperative month
Title
distal bone resorption
Description
resorption of alveolar bone height distal to second molar
Time Frame
6th postoperative month
Secondary Outcome Measure Information:
Title
soft tissue healing index
Description
soft tissue healing around third molar socket
Time Frame
3rd postoperative day
Title
soft tissue healing index
Description
soft tissue healing around third molar socket
Time Frame
7th postoperative day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phong Cu Lam, Master
Organizational Affiliation
University of Medicine and Pharmacy, Ho Chi Minh city
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Medicine and Pharmacy
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam
12. IPD Sharing Statement
Learn more about this trial
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
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