Mastication DisorderPhase 4NCT01583491
Evaluation of Platelet Rich Fibrin on Reduction of Periodontal Problems After Surgical Removal of Mandibular Third Molar
A Phase 4 study testing autologous platlet rich fibrin in people with Mastication Disorder, run by Majid Eshghpour.
Trial summary
The purpose of this study is to determine the influence of platelet rich fibrin to reduction of periodontal problems after surgical removal of third molar. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Mastication Disorder
- What is being tested?
- autologous platlet rich fibrin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to May 2012
- Phase
- Phase 4
- 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
- have 2 impacted third molars
Who cannot join
- periodontal disease
- history of periodontal surgery
About this study
Official title: Evaluation of Platelet Rich Fibrin Efficacy on Reduction of Periodontal Problems
The purpose of this study is to determine the influence of platelet rich fibrin to reduction of periodontal problems after surgical removal of third molar.
Read the detailed description
After extraction or surgical removal of third molar, a deep bony pocket created behind the second molar specially in the mandible. For reduction of this problem, investigators, needed to acceleration tissue healing. For this purpose, investigators used platelet rich fibrin (autologous) and followed patient for 3 months.
- Conditions
- Mastication Disorder
- Being tested
- autologous platlet rich fibrin, one side in control group
- Keywords
- platelet rich fibrin, mandibular third molar, periodontal problem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platlet rich fibrinProcedure or surgery
Also called prf
one dose immediate after surgery
one side in control groupProcedure or surgery
control group insert any things after surgery
| Study group | Role | What they receive |
|---|---|---|
| prf group.peridontal problem | Active comparator | prf insert into surgical site immediate after surgery Receives: Procedure: autologous platlet rich fibrin |
| control group | Placebo comparator | Not described Receives: Procedure: one side in control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastication DisorderStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majid Eshghpour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Majid Eshghpour, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583491
- Sponsor's protocol ID
- 900093
- Status last verified
- Apr 2012
- First submitted
- 7 Dec 2011
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Rich Fibrin Efficacy on Reduction of Periodontal Problems
- ClinicalTrials.gov ID
- NCT01583491
- Acronym / sponsor ID
- 900093
- Conditions
- Mastication Disorder
- Keywords
- platelet rich fibrin, mandibular third molar, periodontal problem
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Majid EshghpourUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 24 Apr 2012 (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 determine the influence of platelet rich fibrin to reduction of periodontal problems after surgical removal of third molar.
Detailed description
After extraction or surgical removal of third molar, a deep bony pocket created behind the second molar specially in the mandible. For reduction of this problem, investigators, needed to acceleration tissue healing. For this purpose, investigators used platelet rich fibrin (autologous) and followed patient for 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prf group.peridontal problem | Active comparator | Procedure: autologous platlet rich fibrinprf insert into surgical site immediate after surgery |
| control group | Placebo comparator | Procedure: one side in control group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- have 2 impacted third molars
Key exclusion criteria (2 listed)
- periodontal disease
- history of periodontal surgery
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 |
|---|---|---|
| autologous platlet rich fibrinAlso: prfone dose immediate after surgery | Procedure or surgery | prf group.peridontal problem |
| one side in control groupcontrol group insert any things after surgery | Procedure or surgery | control group |
Primary outcome
Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing autologous platlet rich fibrin in people with Mastication Disorder, run by Majid Eshghpour.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar (time frame: 4 months). 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 25 Apr 2012.