Bone Graft Particle Size on Bone Vitality and Volume

Not Applicable

Terminated

Conditions: Bilateral Sinus Pneumatization
Posterior Maxillary Ridge Atrophy Due to Extraction

Brief Summary: To determine the effects of small and large bone graft particles vs large particles alone on percent vital bone, percent residual graft material, measured histologically from bone biopsies of the grafted site taken at the time of dental implant placement from subjects undergoing sinus augmentation for the placement of dental implants. Dental radiographs taken post operatively will be used to estimate bone graft volume differences between conditions.

Detailed Description: The proposed study is a Randomized, single-masked, split-mouth, single center study.

About 20 subjects will be screened in order to randomize 10 study subjects. 10 patients who needing bilateral sinus augmentation procedure using the lateral window technique will be randomized using computer generated randomized technique.

At the day of the surgical procedure each tooth sites will be randomized 1:1 into one of the following bone grafts to either the right or left side of the mouth.:

* Bone graft A: A mixture of 25% small-particle cortical allograft, 25% large-particle cortical allograft, 25% small-particle cancellous allograft, and 25% large-particle cancellous allograft is used for one sinus (N=10)

* Bone graft B: 100% large particle cancellous allograft for the contralateral sinus (N=10) Immediately after the sinus augmentation surgery a CBCT will be acquired and will be compared to a second CBCT prior to implant placement in order to compare the volumetric changes in the sinus.

At the visit of implant placement, a bone core will be collected from both sinuses for histomorphometric evaluation to evaluate the residual graft particles, the new vital bone formation and the amount of soft tissue components.

Recruitment & Eligibility

Inclusion Criteria

Good physical health
Capable of maintaining good oral hygiene
Missing posterior maxillary teeth on both sides and less than 5 mm of residual jaw bone requiring maxillary sinus augmentation prior to dental implant placement
Capable and willing to give informed consent

Exclusion Criteria

The presence of underlying medical conditions that may pose an undue risk for sinus surgery
Patients with untreated oral infections
Pregnant and lactating females
Individuals who have the habit of smoking and/or tobacco chewing
Patients not willing to participate in the study

Arm && Interventions

Group	Intervention	Description
Bone Graft A	Puros allograft	Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft
Bone Graft B	Puros allograft	Bone Graft B: 100% large particle cancellous allograft

Primary Outcome Measures

Name	Time	Method
Quality of Bone	After surgery, 8 months, 1 year	Assessment of the quality of bone that is generated in the grafted sinuses by measuring the: percent of inflammatory tissue if any

Secondary Outcome Measures

Name	Time	Method
Bone Volume Stability	After surgery, 8 months, 1 year	Assessment of bone volume stability through CBCT analysis comparing it from the time of placement, 8 months post-grafting and 1 year post-implantation