Oral Ridge PreservationNCT01391767
Histologic Evaluation of Healing Following Tooth Extraction With Ridge Preservation Using NuOss XC and NuOss Particulate
An observational study of Oral Ridge Preservation, run by University of Oklahoma at 1 site in United States.
Trial summary
This study histologically evaluates sites grafted with NuOss XC using ridge preservation techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone mineral with self-expanding collagen) will be compared to sites grafted with NuOss particulate (bovine bone mineral). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Oral Ridge Preservation
- What is being tested?
- NuOss XC
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to May 2013
- Phase
- Observational
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Periodontal Clinic Population at the University of Oklahoma College of Dentistry
Who may be able to join
- may be either male or female
- must be between 18 and 64 years old
- must be of sufficiently good health to undergo routine dental treatment, including the surgical procedures associated with tooth extraction and placement of NuOss XC or NuOss particulate
- must agree to remain in study for 6 months after ridge preservation (grafting)
- must be able to physically, emotionally, and financially undergo the surgical and restorative (implant replacement) procedures planned.
- must not have medical conditions that preclude the removal of indicated teeth and placement of NuOss XC or NuOss particulate
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- must have at least one single-rooted tooth to be extracted
- must consent to tooth extractions, socket augmentation and implant placement
- Patients with or without dental insurance
Who cannot join
- have any requirements for antibiotic premedication for heart murmurs, artificial joints, or any other condition
- have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment
- smoke ≥ 10 cigarettes per day or use other tobacco products
- have a religious or philosophical aversion to having processed bovine bone or collagen used in their mouth
- have taken any investigational drugs anytime in the previous month
- have dental conditions likely to require treatment, necessitating exit from the study such as deep caries, abscesses, or moderate-severe periodontal disease(s).
Show all 9Show fewer
- have sockets that do not have four bony walls intact.
- cannot comply with treatment and follow-up visits for 6 months
- have had significant radiation exposure (occupational, therapeutic, diagnostic).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma College of Dentistry
Oklahoma City, Oklahoma, 73126
About this study
This study histologically evaluates sites grafted with NuOss XC using ridge preservation techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone mineral with self-expanding collagen) will be compared to sites grafted with NuOss particulate (bovine bone mineral).
Read the detailed description
Patients presenting to the University of Oklahoma College of Dentistry Graduate Periodontics Clinic who are treatment planned for tooth extraction and placement of dental implant(s) will be interviewed for possible participation in the study. Forty extraction sites will be included in this study to provide statistical significance.
The ridge preservation sites, using either NuOss XC or NuOss particulate, will be selected randomly. The first site will be selected using the flip of a coin. Thereafter, every other site will be grafted using NuOs XC. The ridge preservation procedure will involve tooth extraction with as little trauma as possible to preserve all four bony socket walls, curettage of the socket to remove all periodontal ligament fibers and granulation tissue, placement of the graft material into the socket and coverings the graft material with long-lasting collagen membrane. Facial and lingual mucoperiosteal flaps will be elevated to facilitate securing of the membrane with long-lasting absorbable sutures. Patient will be given prescriptions for analgesics and antibiotics as necessary.
- Conditions
- Oral Ridge Preservation
- Being tested
- NuOss XC
- Keywords
- Ridge Preservation, Dental Implant, Histology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuOss XCDevice
NuOss XC is a bone grafting material that will be placed in extraction socket site.
| Study group | Role | What they receive |
|---|---|---|
| NuOss XC | Bone grafting material used in this group will be NuOss XC. Receives: Device: NuOss XC | |
| NuOss Particulate | Bone grafting material used in this group will be NuOss Particulate. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological analysis: All sections removed from the osteotomy (hole where implant will be placed) at time of implant placement to be evaluated by a single evaluator, using a semi-quantitative scoring system
Histological processing: Specimens to be trimmed and embedded in methyl methacrylate (MMA). One hematoxylin and eosin (H\&E) stained section, and one Goldner's trichrome-stained section to be taken from each block in a longitudinal plane through the approximate center of each defect.
Goldner's trichrome-stained slides to be scored for the presence of bone and bone marrow as a percent of the total defect area.
H\&E-stained slides to be used to evaluate residual collagen and residual bone mineral as a percent of the total defect area.
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oral Ridge PreservationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- ACE Surgical Supply, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert Carson, DMD, MS, Principal investigator, University of Oklahoma College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391767
- Sponsor's protocol ID
- Nuoss-15852
- Status last verified
- Jul 2013
- First submitted
- 1 Jul 2011
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants. 1995 May-Jun;10(3):303-11.
PubMed 7615326Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
PubMed 12931761
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Evaluation of Healing Following Tooth Extraction With Ridge Preservation Using NuOss XC and NuOss Particulate
- ClinicalTrials.gov ID
- NCT01391767
- Acronym / sponsor ID
- Nuoss-15852
- Conditions
- Oral Ridge Preservation
- Keywords
- Ridge Preservation, Dental Implant, Histology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- ACE Surgical Supply, Inc.
- Study start
- Jul 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 12 Jul 2011 (estimated)
- 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.
This study histologically evaluates sites grafted with NuOss XC using ridge preservation techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone mineral with self-expanding collagen) will be compared to sites grafted with NuOss particulate (bovine bone mineral).
Detailed description
Patients presenting to the University of Oklahoma College of Dentistry Graduate Periodontics Clinic who are treatment planned for tooth extraction and placement of dental implant(s) will be interviewed for possible participation in the study. Forty extraction sites will be included in this study to provide statistical significance.
The ridge preservation sites, using either NuOss XC or NuOss particulate, will be selected randomly. The first site will be selected using the flip of a coin. Thereafter, every other site will be grafted using NuOs XC. The ridge preservation procedure will involve tooth extraction with as little trauma as possible to preserve all four bony socket walls, curettage of the socket to remove all periodontal ligament fibers and granulation tissue, placement of the graft material into the socket and coverings the graft material with long-lasting collagen membrane. Facial and lingual mucoperiosteal flaps will be elevated to facilitate securing of the membrane with long-lasting absorbable sutures. Patient will be given prescriptions for analgesics and antibiotics as necessary.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuOss XC | – | Device: NuOss XCBone grafting material used in this group will be NuOss XC. |
| NuOss Particulate | – | –Bone grafting material used in this group will be NuOss Particulate. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Periodontal Clinic Population at the University of Oklahoma College of Dentistry
Key inclusion criteria (9 listed)
- may be either male or female
- must be between 18 and 64 years old
- must be of sufficiently good health to undergo routine dental treatment, including the surgical procedures associated with tooth extraction and placement of NuOss XC or NuOss particulate
- must agree to remain in study for 6 months after ridge preservation (grafting)
- must be able to physically, emotionally, and financially undergo the surgical and restorative (implant replacement) procedures planned.
Key exclusion criteria (9 listed)
- have any requirements for antibiotic premedication for heart murmurs, artificial joints, or any other condition
- have a history of significant heart, stomach, liver, kidney, blood, immune system or other organ impairment or systemic disease that would prevent their undergoing the proposed treatment
- smoke ≥ 10 cigarettes per day or use other tobacco products
- have a religious or philosophical aversion to having processed bovine bone or collagen used in their mouth
- have taken any investigational drugs anytime in the previous month
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 |
|---|---|---|
| NuOss XCNuOss XC is a bone grafting material that will be placed in extraction socket site. | Device | NuOss XC |
Primary outcome
Histological analysis: All sections removed from the osteotomy (hole where implant will be placed) at time of implant placement to be evaluated by a single evaluator, using a semi-quantitative scoring system
Time frame: 12-18 months
Histological processing: Specimens to be trimmed and embedded in methyl methacrylate (MMA). One hematoxylin and eosin (H\&E) stained section, and one Goldner's trichrome-stained section to be taken from each block in a longitudinal plane through the approximate center of each defect. Goldner's trichrome-stained slides to be scored for the presence of bone and bone marrow as a percent of the total defect area. H\&E-stained slides to be used to evaluate residual collagen and residual bone mineral as a percent of the total defect area.
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 8 Jul 2013.
- Background: PubMed 7615326Jemt T, Lekholm U. Implant treatment in edentulous maxillae: a 5-year follow-up report on patients with different degrees of jaw resorption. Int J Oral Maxillofac Implants. 1995 May-Jun;10(3):303-11.
- Background: PubMed 12931761Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
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Volumetric Efficacy of Alveolar Ridge Preservation
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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.
Robert Carson, DMD, MS principal investigator
University of Oklahoma College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Ridge Preservation, run by University of Oklahoma 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 9 inclusion and 9 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 8 Jul 2013. 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?
Histological analysis: All sections removed from the osteotomy (hole where implant will be placed) at time of implant placement to be evaluated by a single evaluator, using a semi-quantitative scoring system (time frame: 12-18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01391767, which also lists 2 linked publications.
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 8 Jul 2013.