Bone Graft Particle Size on Bone Vitality and Volume

NYU College of Dentistry

Status: Terminated

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

Treatments: Device: Puros allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT04778709

19-00996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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4 participants in 2 patient groups

Bone Graft A

Experimental group

Description:

Bone Graft A: Mixture of 25% small-particle cortical, 25% large particle cortical, 25% small particle cancellous, 25% large particle cancellous allograft

Treatment:

Device: Puros allograft

Bone Graft B

Active Comparator group

Description:

Bone Graft B: 100% large particle cancellous allograft

Treatment:

Device: Puros allograft