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
About this trial
This is an interventional treatment trial for Maxillary Sinus Disease
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
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
NCT ID
NCT03046173
First Posted
January 16, 2017
Last Updated
February 5, 2017
Sponsor
Deyang Stomatological Hospital
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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