Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach
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
1 other identifier
interventional
20
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 16, 2017
CompletedFirst Posted
Study publicly available on registry
February 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedFebruary 8, 2017
February 1, 2017
1.7 years
January 16, 2017
February 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Excellent and good rate of bone repair
X-ray examination was performed to evaluate bone repair as per excellent and good rate.
changes of month 1, month 3 and month 6 after surgery
Secondary Outcomes (1)
Bone density at bone defect sites
changes of month 1, month 3 and month 6 after surgery
Study Arms (2)
the experimental group
EXPERIMENTALThese patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
the control group
EXPERIMENTALThese patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.
Interventions
These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Min Liu, MD
Deyang Stomatological Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
January 16, 2017
First Posted
February 8, 2017
Study Start
May 1, 2014
Primary Completion
January 1, 2016
Study Completion
May 1, 2017
Last Updated
February 8, 2017
Record last verified: 2017-02