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Bone Graft Particle Size on Bone Vitality and Volume

NCT ID: NCT04778709

Last Updated: 2023-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-13

Study Completion Date

2022-02-01

Brief Summary

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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

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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.

Conditions

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Bilateral Sinus Pneumatization Posterior Maxillary Ridge Atrophy Due to Extraction

Keywords

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Sinus floor augmentation Bone graft Allograft Dental implants Maxillary sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Each subject will receive bilateral sinus augmentation. Right and left sinuses will be randomly assigned to Bone Graft A and Bone Graft B.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
CBCT review, core biopsy evaluation and histomorphometry will be performed by a masked investigator.

Study Groups

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Bone Graft A

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

Group Type EXPERIMENTAL

Puros allograft

Intervention Type DEVICE

Bilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus.

Each subject will receive the following bone allograft material:

Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone.

Bone Graft B

Bone Graft B: 100% large particle cancellous allograft

Group Type ACTIVE_COMPARATOR

Puros allograft

Intervention Type DEVICE

Bilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus.

Each subject will receive the following bone allograft material:

Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone.

Interventions

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Puros allograft

Bilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus.

Each subject will receive the following bone allograft material:

Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU College of Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Katerina Georgantza, DDS

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Periodontology and Implant Dentistry

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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19-00996

Identifier Type: -

Identifier Source: org_study_id