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

Maxillary Sinus Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03046173
• Other study ID #: DeyangSH_001
• Status: Active, not recruiting
• Phase: N/A
• First received: January 16, 2017
• Last updated: February 5, 2017
• Start date: May 2014
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Deyang Stomatological Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Maxillary Sinus Disease

Intervention

Other:
• 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.
• hydroxyapatite and autogenous bone
These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Deyang Stomatological Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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