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Assessment of the Quality and Quantity of Bone Regeneration

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ClinicalTrials.gov Identifier: NCT03417375
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmad Kutkut, University of Kentucky

Brief Summary:

The purpose of this study is to histologically and radiographically evaluate the maxillary sinus bone volume and density, with reference to percentage of vital bone present, after four months of grafting with either Osteocel or a cortical-cancellous allograft.

  1. To assess the quality and quantity of the maxillary sinus bone prior to the placement of dental implants and subsequent restorations, approximately 20 patients will be randomly assigned to receive an augmentation of the maxillary sinus region using either Osteocel or a cortical-cancellous allograft.
  2. With the use of pre-operative and four months post-operative CBCT radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Osteocel and the individuals receiving conventional cortical-cancellous allograft material.
  3. Histomorphometric analysis will be used to assess, compare and contrast the quality and the quantity of the new vital bone cells generated when using these different graft materials

Condition or disease Intervention/treatment Phase
Bone Quality and Quantity Procedure: Bilateral Sinus Augmentation Not Applicable

Detailed Description:

Eligible patients will be randomly assigned into one of two treatment groups using a randomization table generated by a computer. The test group (10 sinuses) will receive Osteocel Plus and control group (10 sinuses) will receive conventional cortical-cancellous particulate allograft material. The objective of this research is to serve as a pilot study, gathering information that will guide the design of a larger subsequent study. Little is known about the distribution of bone quality changes in patients who receive Osteocel Plus graft to augment the maxillary sinus. Ten subjects per group is reasonable for a pilot study, providing an 89% probability of estimating the true mean for bone quality and implant stability to within half a standard deviation in each group. These means, along with the observed standard deviations and within-subject correlations that the investigators obtain will prove essential for designing the larger, confirmatory study that constitute the next phase of this research.

A clinical radiographic/surgical guide will be fabricated for each patient to be used for CBCT scan prior to sinus augmentation procedure. The same clinical radiographic/surgical guide will be used for CBCT scan prior to the implant placement to measure the amount of bone regeneration following four months of healing at the exact sites. One line will measure the horizontal width and the other line will measure the vertical height. The horizontal width will be measured at a vertical height of 10 mm from the sinus floor in the sinus cavity based on the conventional average length of dental implant used in implant dentistry. The difference in the measurements for all surgical sites after the grafting procedure and before the implant placement will provide a clinical assessment of the amount of bone regeneration.

Forty trephined core samples will be retrieved surgically from two areas of the grafted lateral window at the time of implant placement. One core sample will be retrieved from the anterior area, approximately 4 mm distal to the anterior tack which was used to fix the resorbable membrane, and the other one will be retrieved from the posterior area, approximately 4 mm mesial of the posterior tack which was used to fix the resorbable membrane. Histomorphometric analysis will be performed on three fields for each section using specialized software. Volume of vital bone, graft remnants, and connective tissue will be measured based on the averages of the percentages at a magnification of 63X. Data will be statistically analyzed using Statistical Package for the Social Sciences (SPSS 13.0 for Windows software) program to compare between test and control groups.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Assessment of the Quality and Quantity of Bone Regeneration in the Maxillary Sinus Using Osteocel With Scaffold or Allograft Materials: A Radiographic and Histomorphometric Randomized Controlled Clinical Study.
Actual Study Start Date : November 17, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Arm Intervention/treatment
Experimental: Osteocel Plus
Experimental product will be placed in one sinus while the control product will be placed in the contralateral sinus. (Randomized)
Procedure: Bilateral Sinus Augmentation
Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.

Active Comparator: alloOss
The control product will be placed in one sinus while the control product will be placed in the contralateral sinus. (Randomized)
Procedure: Bilateral Sinus Augmentation
Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.




Primary Outcome Measures :
  1. Quality of Bone Regeneration (Number of Osteoblasts per histologic section) [ Time Frame: 4 months post-operative of sinus augmentation. ]
    Core samples of bone will be evaluated histomorphometrically for number of osteoblasts present.

  2. Quantity of Bone Regeneration (Linear measurements) [ Time Frame: 3.5 months post-operative of sinus augmentation. ]
    Linear measurement of HEIGHT of bone gain

  3. Quantity of Bone Regeneration (Linear measurements) [ Time Frame: 3.5 months post-operative of sinus augmentation. ]
    Linear measurement of WIDTH of bone gain

  4. Quantity of Bone Regeneration (Linear measurements) [ Time Frame: 3.5 months post-operative of sinus augmentation. ]
    Linear measurement of DEPTH of bone gain



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Must be 22 years old or older. Must have at least one edentulous posterior site requiring grafting. Must have an implant restoration to replace at least one tooth in the edentulous site.

Must be available for the follow-up examinations.

Exclusion Criteria:

Current smokers Dental infections of bone Untreated periodontal disease Pregnant patients or those who are nursing Uncontrolled diabetes (via patient reported A1C) Chemotherapy/Radiation patients Autoimmune diseases Kidney disease Liver disease


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417375


Locations
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United States, Kentucky
University of Kentucky College of Dentistry
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Ahmad Kutkut
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Responsible Party: Ahmad Kutkut, Associate Professor, Restorative Dentistry, University of Kentucky
ClinicalTrials.gov Identifier: NCT03417375    
Other Study ID Numbers: 17-0102-F2L
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes