Concentrated Growth FactorsNCT03180658
Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
A study testing GTR + CGF + bone graft and CGF + bone graft in people with Concentrated Growth Factors and Periodontal Regeneration, run by Jing Qiao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Concentrated Growth Factors, Periodontal Regeneration, Furcation Defects
- What is being tested?
- GTR + CGF + bone graft and CGF + bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to 1 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- II° furcation involvements in mandibular molars
- after periodontal therapy.
Who cannot join
- not healthy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking university School and Hospital of Stomatology
Beijing, Beijing Municipality, 100081
jing qiao, doctor
About this study
Official title: 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.
- Being tested
- GTR + CGF + bone graft, CGF + bone graft
- Medical subject headings
- Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GTR + CGF + bone graftProcedure or surgery
Also called CGF Centrifuge machine
Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements
CGF + bone graftProcedure or surgery
Also called CGF Centrifuge machine
CGF combined with bone graft to treat mandibular furcation involvements
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | GTR+CGF+bone graft, CGF Receives: Procedure: GTR + CGF + bone graft |
| controlled | Active comparator | CGF+bone graft Receives: Procedure: CGF + bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical measurement
Probing depth
Measured: 1 year
clinical parameter
clinical attachment loss
Measured: 1 year
Secondary outcomes (1)
radiographic parameter
cone beam computerized tomographic scanning
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 May 2017
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concentrated Growth FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jing Qiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jing Qiao, Peking University
- Investigators
- yan zu zhang, doctor, Study chair, dean
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180658
- Sponsor's protocol ID
- 81600868
- Status last verified
- Jun 2017
- First submitted
- 29 May 2017
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concentrated Growth Factors in Regenerative Therapy in Furcation Involvements in Humans
- ClinicalTrials.gov ID
- NCT03180658
- Acronym / sponsor ID
- 81600868
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Jing QiaoUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Procedure: GTR + CGF + bone graftGTR+CGF+bone graft, CGF |
| controlled | Active comparator | Procedure: CGF + bone graftCGF+bone graft |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- II° furcation involvements in mandibular molars
- after periodontal therapy.
Key exclusion criteria (1 listed)
- not healthy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GTR + CGF + bone graftAlso: CGF Centrifuge machineGuided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements | Procedure or surgery | experimental |
| CGF + bone graftAlso: CGF Centrifuge machineCGF combined with bone graft to treat mandibular furcation involvements | Procedure or surgery | controlled |
Primary outcome
clinical measurement
Time frame: 1 year
Probing depth
clinical parameter
Time frame: 1 year
clinical attachment loss
1 secondary outcome
radiographic parameter
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yan zu zhang, doctor study chair
dean
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GTR + CGF + bone graft and CGF + bone graft in people with Concentrated Growth Factors and Periodontal Regeneration, run by Jing Qiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact qiao jing, doctor (86-13241892143, donaldshushu@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical measurement (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2017.