Clinical trial NCT04778709: Bone Graft Particle Size on Bone Vitality and Volume
Official title: A Randomized, Split Mouth Study of the Effects of Bone Graft Particle Size on Bone Vitality and Bone Volume Outcomes in Subjects Undergoing Sinus Augmentation for the Placement of Dental Implants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bilateral Sinus Pneumatization
Posterior Maxillary Ridge Atrophy Due to Extraction
Keywords: Sinus floor augmentation
Bone graft
Allograft
Dental implants
Maxillary sinus
Lead sponsor: NYU College of Dentistry
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 4
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of Bone
timeFrame: After surgery, 8 months, 1 year
measure: Quality of Bone
timeFrame: After surgery, 8 months, 1 year
measure: Quality of Bone
timeFrame: After surgery, 8 months, 1 year
Secondary outcomes:
measure: Bone Volume Stability
timeFrame: After surgery, 8 months, 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Department of Periodontology and Implant Dentistry
state: New York
Study officials:
References: