Concentrated Growth Factors in Regenerative Therapy in Fu... | NCT03180658

Studies
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

NCT03180658

Sponsor

Jing Qiao

Status

Unknown status

Last Update Posted

Jun 8, 2017Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Concentrated Growth Factors
Periodontal Regeneration
Furcation Defects

Interventions

GTR + CGF + bone graft
CGF + bone graft

Countries

China

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

Jun 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

May 1, 2020Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

May 29, 2017

First Submission Date that Met QC Criteria

Jun 7, 2017

First Posted Date

Jun 8, 2017Actual

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

Jun 7, 2017

Last Update Posted Date

Jun 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

Objective: To compare the effect of guided tissue regeneration (GTR) + concentrated growth factors (CGF) + bone graft and CGF + bone graft in the treat of II° furcations of human mandibular molars. Methods: At least thirty II°furcation involvements in mandibular molars will be included and randomly divided into two groups. The experimental group will accept GTR + CGF + bone graft therapy, and the control group will accept CGF + bone graft therapy. The clinical examination and cone beam computed tomography (CBCT) will be performed at baseline and 1 year post-surgery.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental	Experimental	GTR+CGF+bone graft, CGF	Procedure: GTR + CGF + bone graft
controlled	Active Comparator	CGF+bone graft	Procedure: CGF + bone graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GTR + CGF + bone graft	Procedure	Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements	experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical measurement	Probing depth	1 year
clinical parameter	clinical attachment loss	1 year

Secondary Outcomes

Measure	Description	Time Frame
radiographic parameter	cone beam computerized tomographic scanning	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

II° furcation involvements in mandibular molars
after periodontal therapy.

Exclusion Criteria:

not healthy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
qiao jing, doctor	Contact	86-13241892143		donaldshushu@aliyun.com

Overall Officials

Name	Affiliation	Role
yan zu zhang, doctor	dean	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking university School and Hospital of Stomatology	Recruiting	Beijing	Beijing Municipality	100081	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017823	Furcation Defects

Ancestor Terms

ID	Term
D010510	Periodontal Diseases
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016025	Bone Transplantation

Ancestor Terms

ID	Term
D016378	Tissue Transplantation
D064987	Cell- and Tissue-Based Therapy
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided