Clinical trial NCT01911819: A Comparison of Bone Formation With Three Different Bone Graft Materials Following Sinus Graft
Official title: A Histomorphometric Analysis of Bone Formation With Three Different Bone Graft Materials Following Sinus Augmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inadequate Bone Height in Maxillary Posterior Area
Keywords: Histomorphometric Analysis
New bone Formation
Sinus Augmentation
Bone Graft Materials
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: American Regent, Inc.
First posted: 2013-07-30
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare new bone formation following bone graft in sinus using three different commercially available bone graft materials. The study hypothesis is that there is no difference in new bone formation among three bone graft materials under microscope.

Detailed description: The purpose of this investigation is to compare new bone formation through histomorphometric analysis following maxillary sinus augmentation using three different bone graft materials. Null Hypothesis is that there is no histomorphometric difference in new bone formation in maxillary sinuses augmented using three different materials; anorganic bovine bone graft (Bio-Oss), anorganic equine bone graft (Equimatrix) and mineralized bone allograft (OSSIF-i sem). Patients who require sinus augmentation prior to implant placement will be selected to participate in this study. All patients will be randomly placed into three groups according to bone graft materials that will be used. Group A (Control group,n=10): Maxillary sinus augmentation using anorganic bovine bone graft (Bio-Oss), Group B (Test group,n=10):Maxillary sinus augmentation using anorganic equine bone graft (Equimatrix), and Group C (Test group,n=10):Maxillary sinus augmentation using mineralized bone allograft (OSSIF-i sem). All the patients will be treated with the same surgical technique consisting of sinus floor augmentation via a lateral approach.After a full-thickness flap reflection to expose the lateral wall of the sinus each antrostomy will be outlined with a carbide round bur and sinus membranes will be carefully elevated. If a perforation to the sinus membrane occurs, and if the perforation is \< 5 mm in diameter and is able to be repaired, the surgeon will continue the procedure. Any perforation \> 5 mm will be excluded from this study. Bone graft materials will be placed into the each sinus compartment for the three groups. After 8 months of healing, biopsy specimen will be collected from the previous antrostomy sites. Histomorphometric measurements of the percentage of vital bone of the area of bone. The percentage of non-bone material (allograft or xenograft) and the percentage of connective tissue will be also analyzed. Then the primary hypothesis will be analyzed statistically.

Eligibility criteria: Inclusion Criteria:

1. Over 18 years old who are able to read and sign written consent form.
2. Patient who has good oral hygiene (Full-mouth plaque score \<25%).
3. Subject would be available for study monitoring.
4. Patients with missing teeth in the maxillary posterior region who will require sinus augmentation f or implant placement. The patients may be partially or completely edentulous.
5. Delayed implant placement approximately 8 months following sinus grafting.

Exclusion Criteria:

A medical history that will complicate the outcome of the study such as:

1. alcohol, drug dependency,
2. signs or symptoms of maxillary sinus disease,
3. current smoker,
4. history of head and neck radiation treatment,
5. poor health or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and/or required follow-up examinations.

Primary outcomes:
measure: The Percentage of Vital Bone in a Total Amount of a Bone Specimen
timeFrame: 24months
Secondary outcomes:
measure: The Percentage of Non-vital Bone/Residual Bone Graft Material in a Bone.
timeFrame: 24months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Dentistry
state: California
Study officials:
affiliation: Loma Linda University School of Dentistry
name: Joseph Kan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: