Evaluation of Platelet Rich Fibrin on Reduction of Period... | NCT01583491

Studies
Evaluation of Platelet Rich Fibrin on Reduction of Periodontal Problems After Surgical Removal of Mandibular Third Molar

NCT01583491

Sponsor

Majid Eshghpour

Status

Unknown status

Last Update Posted

Apr 25, 2012Estimated

Enrollment

30Actual

Phase

Phase 4

Conditions

Mastication Disorder

Interventions

autologous platlet rich fibrin
one side in control group

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Apr 2012Estimated

Completion Date

May 2012Estimated

First Submitted Date

Dec 7, 2011

First Submission Date that Met QC Criteria

Apr 23, 2012

First Posted Date

Apr 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2012

Last Update Posted Date

Apr 25, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prf group.peridontal problem	Active Comparator	prf insert into surgical site immediate after surgery	Procedure: autologous platlet rich fibrin
control group	Placebo Comparator		Procedure: one side in control group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
autologous platlet rich fibrin	Procedure	one dose immediate after surgery	prf group.peridontal problem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar		4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

have 2 impacted third molars

Exclusion Criteria:

periodontal disease
history of periodontal surgery

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D056690	Prolactin-Releasing Hormone
D035061	Control Groups

Ancestor Terms

ID	Term
D007028	Hypothalamic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists

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Browse Branches

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