Maxillary Sinus DiseaseNCT03046173
Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach
A study testing concentrated growth factors and hydroxyapatite and autogenous bone in people with Maxillary Sinus Disease, run by Deyang Stomatological Hospital.
Trial summary
To investigate the effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Maxillary Sinus Disease
- What is being tested?
- concentrated growth factors and hydroxyapatite and autogenous bone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2014to May 2017
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Loss of one or more maxillary molars in the posterior maxillary region
- Occlusogingival distance of > 4 mm
- Residual bone height of 2-5 mm in the posterior maxillary region, no obvious maxillary sinus separation
- No problems with the lungs, heart, or brain
- Normal liver and kidney function
- Normal coagulation function
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- Adequate prosthetic space
- No history of bruxism or temporomandibular joint disorders
- No tumors, cysts and polyps in maxillary sinus
- No acute or chronic maxillary sinusitis
- No acute periodontitis
- No oral mucosal disease
- Age 20-45 years
- Able to tolerate the stress of anesthesia and surgery
Who cannot join
- Residual bone height of < 1 mm in the posterior maxillary region or presence of maxillary sinus mucosa rupture
- Poor control of complex periodontal disease
- Local inflammation or poor oral hygiene
- Poorly treated maxillary disease
- With severe bruxism
- With temporomandibular joint disorders
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- Alcohol consumption and cigarette smoking (20 cigarettes/d)
- Have a history of chemotherapy and radiation therapy in face and neck
- Pregnant
- With coagulation disorders
- With autoimmune disease
- With severe osteoporosis
- With acute maxillary sinusitis
- Unable to tolerate simple surgery because of systemic diseases including severe diabetes mellitus and heart disease
- Unable to provide informed consent
About this study
Official title: Osteogenic Effects of Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach With Simultaneous Implant Placement: a Single-center Randomized Controlled Trial
To investigate the effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation.
Read the detailed description
Maxillary sinus floor elevation via a lateral window approach is the most effective method of overcoming the shortage of bone mass deficiency in atrophic maxillary posterior region. Bone transplantation is considered to be a prerequisite for the success of maxillary sinus floor elevation. Platelet-rich plasma and platelet-rich fibrin have been used to accelerate bone formation, regeneration, and repair. However, few in-depth studies are reported on the effects of concentrated growth factors on new bone formation.
- Conditions
- Maxillary Sinus Disease
- Being tested
- concentrated growth factors, hydroxyapatite and autogenous bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
concentrated growth factorsOther
These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
hydroxyapatite and autogenous boneOther
These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.
| Study group | Role | What they receive |
|---|---|---|
| the experimental group | Experimental | These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group. Receives: Other: concentrated growth factors |
| the control group | Experimental | These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group. Receives: Other: hydroxyapatite and autogenous bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent and good rate of bone repair
X-ray examination was performed to evaluate bone repair as per excellent and good rate.
Measured: changes of month 1, month 3 and month 6 after surgery
Secondary outcomes (1)
Bone density at bone defect sites
The thickness of the cortical bone at the defect sites was measured using a dental cone beam CT scanner to reflect bone density.
Measured: changes of month 1, month 3 and month 6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2017 (estimated)
- Study startMay 2014
- Primary completionJan 2016
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus DiseaseStudies 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, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deyang Stomatological Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Cheng, Deyang Stomatological Hospital
- Investigators
- Min Liu, MD, Principal investigator, Deyang Stomatological Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03046173
- Sponsor's protocol ID
- DeyangSH_001
- Status last verified
- Feb 2017
- First submitted
- 16 Jan 2017
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteogenic Effects of Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach With Simultaneous Implant Placement: a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03046173
- Acronym / sponsor ID
- DeyangSH_001
- Conditions
- Maxillary Sinus Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Deyang Stomatological HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 8 Feb 2017 (estimated)
- 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.
To investigate the effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation.
Detailed description
Maxillary sinus floor elevation via a lateral window approach is the most effective method of overcoming the shortage of bone mass deficiency in atrophic maxillary posterior region. Bone transplantation is considered to be a prerequisite for the success of maxillary sinus floor elevation. Platelet-rich plasma and platelet-rich fibrin have been used to accelerate bone formation, regeneration, and repair. However, few in-depth studies are reported on the effects of concentrated growth factors on new bone formation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the experimental group | Experimental | Other: concentrated growth factorsThese patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group. |
| the control group | Experimental | Other: hydroxyapatite and autogenous boneThese patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Loss of one or more maxillary molars in the posterior maxillary region
- Occlusogingival distance of > 4 mm
- Residual bone height of 2-5 mm in the posterior maxillary region, no obvious maxillary sinus separation
- No problems with the lungs, heart, or brain
- Normal liver and kidney function
Key exclusion criteria (15 listed)
- Residual bone height of < 1 mm in the posterior maxillary region or presence of maxillary sinus mucosa rupture
- Poor control of complex periodontal disease
- Local inflammation or poor oral hygiene
- Poorly treated maxillary disease
- With severe bruxism
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 |
|---|---|---|
| concentrated growth factorsThese patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group. | Other | the experimental group |
| hydroxyapatite and autogenous boneThese patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group. | Other | the control group |
Primary outcome
Excellent and good rate of bone repair
Time frame: changes of month 1, month 3 and month 6 after surgery
X-ray examination was performed to evaluate bone repair as per excellent and good rate.
1 secondary outcome
Bone density at bone defect sites
Time frame: changes of month 1, month 3 and month 6 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Min Liu, MD principal investigator
Deyang Stomatological Hospital
Questions about this trial
What is this clinical trial studying?
A study testing concentrated growth factors and hydroxyapatite and autogenous bone in people with Maxillary Sinus Disease, run by Deyang Stomatological Hospital.
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 14 inclusion and 15 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 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excellent and good rate of bone repair (time frame: changes of month 1, month 3 and month 6 after surgery). 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 Feb 2017.