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

Primary Purpose

Maxillary Sinus Disease

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
concentrated growth factors
hydroxyapatite and autogenous bone
Sponsored by
Deyang Stomatological Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Sinus Disease

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    the experimental group

    the control group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Excellent and good rate of bone repair
    X-ray examination was performed to evaluate bone repair as per excellent and good rate.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    January 16, 2017
    Last Updated
    February 5, 2017
    Sponsor
    Deyang Stomatological Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03046173
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    May 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Deyang Stomatological Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maxillary Sinus Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    the experimental group
    Arm Type
    Experimental
    Arm Description
    These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
    Arm Title
    the control group
    Arm Type
    Experimental
    Arm Description
    These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.
    Intervention Type
    Other
    Intervention Name(s)
    concentrated growth factors
    Intervention Description
    These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
    Intervention Type
    Other
    Intervention Name(s)
    hydroxyapatite and autogenous bone
    Intervention Description
    These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.
    Primary Outcome Measure Information:
    Title
    Excellent and good rate of bone repair
    Description
    X-ray examination was performed to evaluate bone repair as per excellent and good rate.
    Time Frame
    changes of month 1, month 3 and month 6 after surgery
    Secondary Outcome Measure Information:
    Title
    Bone density at bone defect sites
    Description
    The thickness of the cortical bone at the defect sites was measured using a dental cone beam CT scanner to reflect bone density.
    Time Frame
    changes of month 1, month 3 and month 6 after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Min Liu, MD
    Organizational Affiliation
    Deyang Stomatological Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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