Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

June 7, 2017 updated by: Jing Qiao

The Effect of Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100081
        • Recruiting
        • Peking University School and Hospital of Stomatology
        • Contact:
          • jing qiao, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • II° furcation involvements in mandibular molars
  • after periodontal therapy.

Exclusion Criteria:

  • not healthy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
GTR+CGF+bone graft, CGF
Procedure: GTR + CGF + bone graft
Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements
Other Names:
  • CGF Centrifuge machine
Active Comparator: controlled
CGF+bone graft
Procedure: CGF + bone graft
CGF combined with bone graft to treat mandibular furcation involvements
Other Names:
  • CGF Centrifuge machine

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jing Qiao

Investigators

  • Study Chair: yan zu zhang, doctor, dean

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2017

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

May 29, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 81600868

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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