Platelet-rich FibrinNCT05866965
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
A study testing PRF and standard third molar surgical removal in people with Platelet-rich Fibrin, run by Lam Cu Phong at 1 site in Vietnam.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet-rich Fibrin
- What is being tested?
- PRF and standard third molar surgical removal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Dec 2019to 1 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- PRF, standard third molar surgical removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFOther
centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin
standard third molar surgical removalOther
standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy Receives: 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 Receives: Other: PRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
periodontal pocket depth
periodontal pocket depth at distal buccal and distal lingual side of second molar
Measured: 1rst postoperative month
periodontal pocket depth
periodontal pocket depth at distal buccal and distal lingual side of second molar
Measured: 3rst postoperative month
periodontal pocket depth
periodontal pocket depth at distal buccal and distal lingual side of second molar
Measured: 6rst postoperative month
distal bone resorption
resorption of alveolar bone height distal to second molar
Measured: 3rd postoperative month
distal bone resorption
resorption of alveolar bone height distal to second molar
Measured: 6th postoperative month
Secondary outcomes (2)
soft tissue healing index
soft tissue healing around third molar socket
Measured: 3rd postoperative day
soft tissue healing index
soft tissue healing around third molar socket
Measured: 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Dec 2019
- Primary completion1 Jun 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-rich FibrinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- split-mouth study, 1 side would be the study side and other side would be control side
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lam Cu Phong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lam Cu Phong, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Phong Cu Lam, Master, Principal investigator, University of Medicine and Pharmacy, Ho Chi Minh city
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866965
- Sponsor's protocol ID
- lamphongrhm
- Status last verified
- May 2023
- First submitted
- 27 Apr 2023
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT05866965
- Acronym / sponsor ID
- lamphongrhm
- Conditions
- Platelet-rich Fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Lam Cu PhongUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- split-mouth study, 1 side would be the study side and other side would be control side
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Other: standard third molar surgical removalstandard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy |
| PRF | Experimental | Other: PRFPRF was applied in third molar socket after removal following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRFcentrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin | Other | PRF |
| standard third molar surgical removalstandard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy | Other | control |
Primary outcome
periodontal pocket depth
Time frame: 1rst postoperative month
periodontal pocket depth at distal buccal and distal lingual side of second molar
periodontal pocket depth
Time frame: 3rst postoperative month
periodontal pocket depth at distal buccal and distal lingual side of second molar
periodontal pocket depth
Time frame: 6rst postoperative month
periodontal pocket depth at distal buccal and distal lingual side of second molar
distal bone resorption
Time frame: 3rd postoperative month
resorption of alveolar bone height distal to second molar
distal bone resorption
Time frame: 6th postoperative month
resorption of alveolar bone height distal to second molar
2 secondary outcomes
soft tissue healing index
Time frame: 3rd postoperative day
soft tissue healing index
Time frame: 7th postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phong Cu Lam, Master principal investigator
University of Medicine and Pharmacy, Ho Chi Minh city
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF and standard third molar surgical removal in people with Platelet-rich Fibrin, run by Lam Cu Phong at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
periodontal pocket depth (time frame: 1rst postoperative month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.