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

Not Applicable

• Conditions: Maxillary Sinus Disease
• Interventions: Other: concentrated growth factors; Other: hydroxyapatite and autogenous bone

• Registration Number: NCT03046173
• Lead Sponsor: Deyang Stomatological Hospital

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.

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2016-01
• Study First Submitted: 2017-01-16
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-05
• Last Update Submitted: 2017-02-05
• Study First Posted: 2017-02-08
• Last Update Posted: 2017-02-08
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
the experimental group	concentrated growth factors	These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
the control group	hydroxyapatite and autogenous bone	These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.

Primary Outcome Measures

Name	Time	Method
Excellent and good rate of bone repair	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.

Secondary Outcome Measures

Name	Time	Method
Bone density at bone defect sites	changes of month 1, month 3 and month 6 after surgery	The thickness of the cortical bone at the defect sites was measured using a dental cone beam CT scanner to reflect bone density.