CClinicalTrials.gg
Status unknownNCT03180658Updated Jun 8, 2017

Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans

An interventional study of GTR + CGF + bone graft and CGF + bone graft in Concentrated Growth Factors, Periodontal Regeneration and Furcation Defects, sponsored by Jing Qiao. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-08.

Sponsored by Jing Qiao · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Concentrated Growth Factors
  • Periodontal Regeneration
  • Furcation Defects

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03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • not healthy
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    experimental

    GTR+CGF+bone graft, CGF

    Procedure: GTR + CGF + bone graft

  • Active comparator
    controlled

    CGF+bone graft

    Procedure: CGF + bone graft

Interventions

  • ProcedureGTR + CGF + bone graft

    Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements

    Also known as: CGF Centrifuge machine

  • ProcedureCGF + bone graft

    CGF combined with bone graft to treat mandibular furcation involvements

    Also known as: CGF Centrifuge machine

05

What researchers measure

Primary outcomes

  1. clinical measurement

    Probing depth

    Time frame: 1 year

  2. clinical parameter

    clinical attachment loss

    Time frame: 1 year

Secondary outcomes

  1. radiographic parameter

    cone beam computerized tomographic scanning

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Peking university School and Hospital of Stomatology
    Beijing, Beijing 100081, China
    • jing qiao, doctor · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03180658
Lead sponsor
Jing Qiao
Responsible party
Jing Qiao (Principal Investigator, Peking University) — Sponsor-investigator
First posted
Jun 8, 2017
Start date
May 1, 2017
Primary completion
May 1, 2020 (estimated)
Completion
Jul 1, 2020 (estimated)
Last update
Jun 8, 2017

Study contacts

qiao jing, doctor
Contact
donaldshushu@aliyun.com
86-13241892143
yan zu zhang, doctor
study chair · dean

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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