Alveolar Process DefectPhase 4NCT02127112
Ridge Augmentation Comparing a Block Allograft to a Demineralized Bone Matrix Allograft.
A Phase 4 study testing Block Allograft plus Matrix Allograft and Moldable Matrix Allograft in people with Alveolar Process Defect, run by University of Louisville at 2 sites in United States.
Trial summary
This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Process Defect
- What is being tested?
- Block Allograft plus Matrix Allograft and Moldable Matrix Allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to May 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Who cannot join
- Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergy to any of the materials that will be used in the study.
- Smokers.
- Patients who need prophylactic antibiotics prior to dental procedures.
- Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV bisphosphonates.
- Patients who are pregnant
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Graduate Periodontics Clinic, University of Louisville
Louisville, Kentucky, 40202
U of L Dental School
Louisville, Kentucky, 40205
About this study
Official title: Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus Optecure Containing Cortico-Cancellous Chips Versus Optecure Containing Cortico-Cancellous Chips Alone.
This study with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.
Read the detailed description
The patients' treatment will be randomly assigned by coin toss done by the mentor immediately after flap reflection. The examiner will be blinded to the treatment and will not have access to information indicating treatment assignment. The examiner will never see the patient between the time of grafting and complete healing at 4 months. The surgical procedure will consist of the reflection of a split-thickness flap to expose the alveolar ridge. Following complete exposure of the surgical site, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. After initial surgical measurements, numerous cortical perforations will be performed with a round bur in the area of the augmentation. The control group will receive a block graft and bone screw for stabilization, with voids being filled by the Optecure+CCC®. The test group therapy will include graft with the Optecure+CCC® and the use of Bone Pin® for space maintenance. Horizontal dimension will be established by graft dimensions, bone screws, or bone pins when necessary, for each planned implant area. Longer span edentulous spaces will be divided into individual sites as follows: 5 mm from natural teeth to future mid-implant sites and 7 mm between two future mid-implant sites. The bone pins and bone blocks with bone screws will be placed to allow enough exposure for augmentation to achieve 9 mm horizontal width available for implant placement. Vertical and horizontal measurements will again be taken with the acrylic occlusal stent and calipers prior to flap closure. An resorbable membrane will cover both test and control groups. A monofilament suture material will be used. The surgical procedures will be documented with clinical photographs.
- Conditions
- Alveolar Process Defect
- Being tested
- Block Allograft plus Matrix Allograft, Moldable Matrix Allograft
- Keywords
- Ridge Augmentation, Bone regeneration, Guided Bone Regeneration, Partially Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Block Allograft plus Matrix AllograftProcedure or surgery
Also called Cancellous block allograft, Optecure + CCC
A cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment.
Moldable Matrix AllograftProcedure or surgery
Also called Optecure + CCC, Resorbable bone pins
The test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins.
| Study group | Role | What they receive |
|---|---|---|
| Block Allograft plus Matrix Allograft | Active comparator | The positive control treatment will include a block allograft plus a demineralized bone matrix moldable allograft. Receives: Procedure: Block Allograft plus Matrix Allograft; Procedure: Moldable Matrix Allograft |
| Moldable Matrix Allograft | Experimental | In the test arm of the study the treatment will include a demineralized bone matrix moldable allograft. Receives: Procedure: Moldable Matrix Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Site width (horizontal) changes by comparing the pre- to post-augmentation dimensions of hard tissues.
Measurement of the horizontal changes will be completed with a manual periodontal probe
Measured: 4 months
Secondary outcomes (2)
Site height (vertical) changes by comparing the pre- to the post-augmentation dimensions of hard tissues.
Measurement of of height will be used with an acrylic stent and a manual periodontal probe.
Measured: 4 months
Histologic composition of the healed ridge.
At the time of re-entry, a trephine core specimen will be taken. This specimen will be examined under a microscope to determine the vital bone characteristics.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Process DefectStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henry Greenwell, University of Louisville
- Investigators
- Henry Greenwell, DMD, MSD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127112
- Sponsor's protocol ID
- 14.0265
- Status last verified
- Dec 2016
- First submitted
- 28 Apr 2014
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus Optecure Containing Cortico-Cancellous Chips Versus Optecure Containing Cortico-Cancellous Chips Alone.
- ClinicalTrials.gov ID
- NCT02127112
- Acronym / sponsor ID
- 14.0265
- Conditions
- Alveolar Process Defect
- Keywords
- Ridge Augmentation, Bone regeneration, Guided Bone Regeneration, Partially Edentulous
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 30 Apr 2014 (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 with compare the ridge dimension changes for a block allograft vs. a demineralized bone matrix moldable allograft.
Detailed description
The patients' treatment will be randomly assigned by coin toss done by the mentor immediately after flap reflection. The examiner will be blinded to the treatment and will not have access to information indicating treatment assignment. The examiner will never see the patient between the time of grafting and complete healing at 4 months. The surgical procedure will consist of the reflection of a split-thickness flap to expose the alveolar ridge. Following complete exposure of the surgical site, vertical measurements will be taken with the acrylic occlusal stent in place, and horizontal measurements with a specially designed digital caliper. After initial surgical measurements, numerous cortical perforations will be performed with a round bur in the area of the augmentation. The control group will receive a block graft and bone screw for stabilization, with voids being filled by the Optecure+CCC®. The test group therapy will include graft with the Optecure+CCC® and the use of Bone Pin® for space maintenance. Horizontal dimension will be established by graft dimensions, bone screws, or bone pins when necessary, for each planned implant area. Longer span edentulous spaces will be divided into individual sites as follows: 5 mm from natural teeth to future mid-implant sites and 7 mm between two future mid-implant sites. The bone pins and bone blocks with bone screws will be placed to allow enough exposure for augmentation to achieve 9 mm horizontal width available for implant placement. Vertical and horizontal measurements will again be taken with the acrylic occlusal stent and calipers prior to flap closure. An resorbable membrane will cover both test and control groups. A monofilament suture material will be used. The surgical procedures will be documented with clinical photographs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block Allograft plus Matrix Allograft | Active comparator | Procedure: Block Allograft plus Matrix Allograft, Procedure: Moldable Matrix AllograftThe positive control treatment will include a block allograft plus a demineralized bone matrix moldable allograft. |
| Moldable Matrix Allograft | Experimental | Procedure: Moldable Matrix AllograftIn the test arm of the study the treatment will include a demineralized bone matrix moldable allograft. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Key exclusion criteria (7 listed)
- Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergy to any of the materials that will be used in the study.
- Smokers.
- Patients who need prophylactic antibiotics prior to dental procedures.
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 |
|---|---|---|
| Block Allograft plus Matrix AllograftAlso: Cancellous block allograft, Optecure + CCCA cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment. | Procedure or surgery | Block Allograft plus Matrix Allograft |
| Moldable Matrix AllograftAlso: Optecure + CCC, Resorbable bone pinsThe test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins. | Procedure or surgery | Block Allograft plus Matrix Allograft, Moldable Matrix Allograft |
Primary outcome
Site width (horizontal) changes by comparing the pre- to post-augmentation dimensions of hard tissues.
Time frame: 4 months
Measurement of the horizontal changes will be completed with a manual periodontal probe
2 secondary outcomes
Site height (vertical) changes by comparing the pre- to the post-augmentation dimensions of hard tissues.
Time frame: 4 months
Histologic composition of the healed ridge.
Time frame: 4 month
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 Dec 2016.
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.
Henry Greenwell, DMD, MSD principal investigator
University of Louisville
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Block Allograft plus Matrix Allograft and Moldable Matrix Allograft in people with Alveolar Process Defect, run by University of Louisville at 2 sites 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 3 inclusion and 7 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 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Site width (horizontal) changes by comparing the pre- to post-augmentation dimensions of hard tissues. (time frame: 4 months). 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 8 Dec 2016; AzTrials last refreshed its copy on 1 Nov 2026.