Back to resultsConcentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
Primary Purpose
Concentrated Growth Factors, Periodontal Regeneration, Furcation Defects
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
GTR + CGF + bone graft
CGF + bone graft
Sponsored by
About this trial
This is an interventional treatment trial for Concentrated Growth Factors
Eligibility Criteria
Inclusion Criteria:
- II° furcation involvements in mandibular molars
- after periodontal therapy.
Exclusion Criteria:
- not healthy
Sites / Locations
- Peking university School and Hospital of StomatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
experimental
controlled
Arm Description
GTR+CGF+bone graft, CGF
CGF+bone graft
Outcomes
Primary Outcome Measures
clinical measurement
Probing depth
clinical parameter
clinical attachment loss
Secondary Outcome Measures
radiographic parameter
cone beam computerized tomographic scanning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03180658
Brief Title
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
Official Title
The Effect of Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jing Qiao
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concentrated Growth Factors, Periodontal Regeneration, Furcation Defects
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental
Arm Type
Experimental
Arm Description
GTR+CGF+bone graft, CGF
Arm Title
controlled
Arm Type
Active Comparator
Arm Description
CGF+bone graft
Intervention Type
Procedure
Intervention Name(s)
GTR + CGF + bone graft
Other Intervention Name(s)
CGF Centrifuge machine
Intervention Description
Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements
Intervention Type
Procedure
Intervention Name(s)
CGF + bone graft
Other Intervention Name(s)
CGF Centrifuge machine
Intervention Description
CGF combined with bone graft to treat mandibular furcation involvements
Primary Outcome Measure Information:
Title
clinical measurement
Description
Probing depth
Time Frame
1 year
Title
clinical parameter
Description
clinical attachment loss
Time Frame
1 year
Secondary Outcome Measure Information:
Title
radiographic parameter
Description
cone beam computerized tomographic scanning
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
II° furcation involvements in mandibular molars
after periodontal therapy.
Exclusion Criteria:
not healthy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
qiao jing, doctor
Phone
86-13241892143
Email
donaldshushu@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yan zu zhang, doctor
Organizational Affiliation
dean
Official's Role
Study Chair
Facility Information:
Facility Name
Peking university School and Hospital of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing qiao, doctor
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
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