Bone Quality and QuantityNCT03417375
Assessment of the Quality and Quantity of Bone Regeneration
A study testing Bilateral Sinus Augmentation in people with Bone Quality and Quantity, run by Ahmad Kutkut at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Quality and Quantity
- What is being tested?
- Bilateral Sinus Augmentation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky College of Dentistry
Lexington, Kentucky, 40536
About this study
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.
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.
- 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.
- 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.
- 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
Read the 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.
- Conditions
- Bone Quality and Quantity
- Being tested
- Bilateral Sinus Augmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Sinus AugmentationProcedure or surgery
Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.
| Study group | Role | What they receive |
|---|---|---|
| Osteocel Plus | Experimental | Experimental product will be placed in one sinus while the control product will be placed in the contralateral sinus. (Randomized) Receives: Procedure: Bilateral Sinus Augmentation |
| alloOss | Active comparator | The control product will be placed in one sinus while the control product will be placed in the contralateral sinus. (Randomized) Receives: Procedure: Bilateral Sinus Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bone Regeneration (Number of Osteoblasts per histologic section)
Core samples of bone will be evaluated histomorphometrically for number of osteoblasts present.
Measured: 4 months post-operative of sinus augmentation.
Quantity of Bone Regeneration (Linear measurements)
Linear measurement of HEIGHT of bone gain
Measured: 3.5 months post-operative of sinus augmentation.
Quantity of Bone Regeneration (Linear measurements)
Linear measurement of WIDTH of bone gain
Measured: 3.5 months post-operative of sinus augmentation.
Quantity of Bone Regeneration (Linear measurements)
Linear measurement of DEPTH of bone gain
Measured: 3.5 months post-operative of sinus augmentation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start17 Nov 2017
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Quality and QuantityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmad Kutkut
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmad Kutkut, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417375
- Sponsor's protocol ID
- 17-0102-F2L
- Status last verified
- Oct 2020
- First submitted
- 11 Jan 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03417375
- Acronym / sponsor ID
- 17-0102-F2L
- Conditions
- Bone Quality and Quantity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ahmad KutkutUniversity, hospital or other
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
- 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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteocel Plus | Experimental | Procedure: Bilateral Sinus AugmentationExperimental product will be placed in one sinus while the control product will be placed in the contralateral sinus. (Randomized) |
| alloOss | Active comparator | Procedure: Bilateral Sinus AugmentationThe control product will be placed in one sinus while the control product will be placed in the contralateral sinus. (Randomized) |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Sinus AugmentationLateral window sinus augmentation with core samples harvested from the window following 4 months of healing. | Procedure or surgery | Osteocel Plus, alloOss |
Primary outcome
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.
Quantity of Bone Regeneration (Linear measurements)
Time frame: 3.5 months post-operative of sinus augmentation.
Linear measurement of HEIGHT of bone gain
Quantity of Bone Regeneration (Linear measurements)
Time frame: 3.5 months post-operative of sinus augmentation.
Linear measurement of WIDTH of bone gain
Quantity of Bone Regeneration (Linear measurements)
Time frame: 3.5 months post-operative of sinus augmentation.
Linear measurement of DEPTH of bone gain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral Sinus Augmentation in people with Bone Quality and Quantity, run by Ahmad Kutkut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Bone Regeneration (Number of Osteoblasts per histologic section) (time frame: 4 months post-operative of sinus augmentation.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2020.