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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03046173
Enrollment
20
Registered
2017-02-08
Start date
2014-05-31
Completion date
2017-05-31
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Maxillary Sinus Disease

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.

Interventions

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

OTHERhydroxyapatite and autogenous bone

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

Sponsors

Deyang Stomatological Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Excellent and good rate of bone repairchanges of month 1, month 3 and month 6 after surgeryX-ray examination was performed to evaluate bone repair as per excellent and good rate.

Secondary

MeasureTime frameDescription
Bone density at bone defect siteschanges of month 1, month 3 and month 6 after surgeryThe thickness of the cortical bone at the defect sites was measured using a dental cone beam CT scanner to reflect bone density.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026