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

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.

Study Overview

• Status: Unknown
• Conditions: Maxillary Sinus Disease
• Intervention / Treatment: Other: concentrated growth factors; Other: hydroxyapatite and autogenous bone

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Deyang Stomatological Hospital
• Investigators: Principal Investigator: Min Liu, MD, Deyang Stomatological Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Anticipated): May 1, 2017

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Paranasal Sinus Diseases; Molecular Mechanisms of Pharmacological Action; Mitosis Modulators; Mitogens
• Other Study ID Numbers: DeyangSH_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED