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

D

Deyang Stomatological Hospital

Status

Unknown

Conditions

Maxillary Sinus Disease

Treatments

Other: hydroxyapatite and autogenous bone
Other: concentrated growth factors

Study type

Interventional

Funder types

Other

Identifiers

NCT03046173
DeyangSH_001

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

20 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

20 participants in 2 patient groups

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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