Fibrin/Therapeutic UseNCT02890680
Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery
A study testing Platelet-rich fibrin in people with Fibrin/Therapeutic Use and Blood Platelets, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin. Read more about this study
- Who is it for?
- Ages 16 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibrin/Therapeutic Use, Blood Platelets, Molar, Third
- What is being tested?
- Platelet-rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Jan 2017
- 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 16 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy patients
- Preoperative platelet count higher than 150,00/ mm3
- Patient who required bilateral mandibular third molar extractions
Who cannot join
- Smokers patients
- Alcoholics patients
- Patients whom the inferior second molar was missing
- Patients who had acute pericoronitis on the inferior third molar
- Severe periodontal disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Clinical Trial Evaluation of Bone Regeneration After Impacted Third Molar Surgery With the of Platelet-rich Fibrin: Pilot Study
The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin.
- Being tested
- Platelet-rich fibrin, Control group
- Keywords
- platelet-rich fibrin, third molar, bone regeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrinProcedure or surgery
Control groupProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich fibrin group | Experimental | Use platelet-rich fibrin after mandibular third molar extraction Receives: Procedure: Platelet-rich fibrin |
| Control group | Placebo comparator | mandibular third molar extraction Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone density through tomography evaluation
Measured: Change from Baseline bone measurement at three months after surgery
Secondary outcomes (5)
Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation
Measured: Change from baseline at 3 months after surgery
Pain through Visual Analogue Scale
Measured: 1st day after surgery
Pain through Visual Analogue Scale
Measured: 3rd day after surgery
Pain through Visual Analogue Scale
Measured: 7th day after surgery
Soft tissue healing through Clinical evaluation numeric scale
Measured: 7th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrin/Therapeutic UseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University
- Investigators
- João Vitor Canellas, DDS; MSc, Principal investigator, Rio de Janeiro University State
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890680
- Sponsor's protocol ID
- CAAE 56621216.5.0000.5259
- Status last verified
- Apr 2017
- First submitted
- 24 Aug 2016
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Clinical Trial Evaluation of Bone Regeneration After Impacted Third Molar Surgery With the of Platelet-rich Fibrin: Pilot Study
- ClinicalTrials.gov ID
- NCT02890680
- Acronym / sponsor ID
- CAAE 56621216.5.0000.5259
- Keywords
- platelet-rich fibrin, third molar, bone regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich fibrin group | Experimental | Procedure: Platelet-rich fibrinUse platelet-rich fibrin after mandibular third molar extraction |
| Control group | Placebo comparator | Procedure: Control groupmandibular third molar extraction |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Healthy patients
- Preoperative platelet count higher than 150,00/ mm3
- Patient who required bilateral mandibular third molar extractions
Key exclusion criteria (5 listed)
- Smokers patients
- Alcoholics patients
- Patients whom the inferior second molar was missing
- Patients who had acute pericoronitis on the inferior third molar
- Severe periodontal disease
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 |
|---|---|---|
| Platelet-rich fibrin | Procedure or surgery | Platelet-rich fibrin group |
| Control group | Procedure or surgery | Control group |
Primary outcome
Change in bone density through tomography evaluation
Time frame: Change from Baseline bone measurement at three months after surgery
5 secondary outcomes
Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation
Time frame: Change from baseline at 3 months after surgery
Pain through Visual Analogue Scale
Time frame: 1st day after surgery
Pain through Visual Analogue Scale
Time frame: 3rd day after surgery
Pain through Visual Analogue Scale
Time frame: 7th day after surgery
Soft tissue healing through Clinical evaluation numeric scale
Time frame: 7th day after surgery
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 12 Apr 2017.
Related trials for Fibrin/Therapeutic Use
Not yet recruiting
Leukocyte- and Platelet-Rich Fibrin in the Surgical Treatment of Medication-related Osteonecrosis of the Jaw
Osteonecrosis of the Jaw
Not yet recruitingPhase 3
Evaluation of The Periodontal Parameters Following Non-Surgical Periodontal Therapy With and Without Adjunctive Use of Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial
Periodontitis (Stage 3)
RecruitingPhase 2
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
Diabetic Foot Ulcer, Type 1 Diabetes Mellitus
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.
João Vitor Canellas, DDS; MSc principal investigator
Rio de Janeiro University State
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-rich fibrin in people with Fibrin/Therapeutic Use and Blood Platelets, run by Rio de Janeiro State University at 1 site in Brazil.
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 3 inclusion and 5 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 12 Apr 2017. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Change in bone density through tomography evaluation (time frame: Change from Baseline bone measurement at three months after surgery). 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 12 Apr 2017.