Clinical trial NCT03046173: Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Sinus Disease
Lead sponsor: Deyang Stomatological Hospital
Sponsor class: OTHER
First posted: 2017-02-08
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Excellent and good rate of bone repair
timeFrame: changes of month 1, month 3 and month 6 after surgery
Secondary outcomes:
measure: Bone density at bone defect sites
timeFrame: changes of month 1, month 3 and month 6 after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Deyang Stomatological Hospital
name: Min Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: