Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Maxillary Sinus Disease

Intervention / Treatment
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* Other: concentrated growth factors
* Other: hydroxyapatite and autogenous bone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the experimental group<br>These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group. | Other: concentrated growth factors<br>* These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.<br>|
| Experimental: the control group<br>These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group. | Other: hydroxyapatite and autogenous bone<br>* These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | changes of month 1, month 3 and month 6 after surgery |