Alveolar Ridge DeficiencyNCT01905280
Ridge Preservation Comparing 2 Membranes
A study testing Non-resorbable membrane and Acellular dermal matrix in people with Alveolar Ridge Deficiency, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Deficiency
- What is being tested?
- Non-resorbable membrane and Acellular dermal matrix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Who cannot join
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics.
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- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics Clinic University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.
Read the detailed description
30 patients will be selected that meet the following criteria:
Inclusion Criteria
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics.
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
- Pregnant patients.
- Conditions
- Alveolar Ridge Deficiency
- Being tested
- Non-resorbable membrane, Acellular dermal matrix
- Keywords
- allograft, acellular dermal matrix, alveolar ridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-resorbable membraneProcedure or surgery
Also called PTFE or Cytoplast
The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.
Acellular dermal matrixProcedure or surgery
Also called Acellular dermal matrix allograft, Alloderm
The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Acellular dermal matrix | Experimental | A ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane. Receives: Procedure: Acellular dermal matrix |
| Non-resorbable membrane | Active comparator | A ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane. Receives: Procedure: Non-resorbable membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crestal ridge width
The width of the ridge at the crest will be measured with a digital caliper.
Measured: 4 months
Secondary outcomes (1)
Percent vital bone
Percent vital bone at the graft site will be determined from a trephine core sample.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Ridge DeficiencyStudies 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
- Outcomes assessor
- Enrolment
- 24 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, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905280
- Sponsor's protocol ID
- 13.0330
- Status last verified
- Dec 2016
- First submitted
- 12 Jul 2013
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
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 Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.
- ClinicalTrials.gov ID
- NCT01905280
- Acronym / sponsor ID
- 13.0330
- Conditions
- Alveolar Ridge Deficiency
- Keywords
- allograft, acellular dermal matrix, alveolar ridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jul 2013 (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.
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.
Detailed description
30 patients will be selected that meet the following criteria:
Inclusion Criteria
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
- Patients who need prophylactic antibiotics.
- Previous head and neck radiation therapy.
- Chemotherapy in the previous 12 months.
- Patients on long term NSAID or steroid therapy.
- Pregnant patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acellular dermal matrix | Experimental | Procedure: Acellular dermal matrixA ridge preservation graft will be performed and then covered using acellular dermal matrix as a membrane. |
| Non-resorbable membrane | Active comparator | Procedure: Non-resorbable membraneA ridge preservation graft will be performed and then covered using a non-resorbable PTFE membrane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth.
- Healthy male or female who is at least 18 years old.
- Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
Key exclusion criteria (10 listed)
- Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- Presence or history of osteonecrosis of jaws.
- Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- Patients who have been treated with oral bisphosphonates for more than three years.
- Patients with an allergy to any material or medication used in the study.
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 |
|---|---|---|
| Non-resorbable membraneAlso: PTFE or CytoplastThe ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery. | Procedure or surgery | Non-resorbable membrane |
| Acellular dermal matrixAlso: Acellular dermal matrix allograft, AllodermThe ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery. | Procedure or surgery | Acellular dermal matrix |
Primary outcome
Crestal ridge width
Time frame: 4 months
The width of the ridge at the crest will be measured with a digital caliper.
1 secondary outcome
Percent vital bone
Time frame: 4 months
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.
Related trials for Alveolar Ridge Deficiency
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Autogenous and Xenograft Bone Mix in Alveolar Ridge Reconstruction
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Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
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Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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Shell Technique for Implant Site Development
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Effectiveness of Subepithelial Connective Tissue Graft as an Autogenous Barrier Membrane for Hard and Soft Tissue Augmentation in Horizontally Deficient Ridges During Delayed Implant Placement
Horizontally Deficient Alveolar Ridges, Hard and Soft Tissue Augmentation During Delayed Implant Placement
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 principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-resorbable membrane and Acellular dermal matrix in people with Alveolar Ridge Deficiency, run by University of Louisville 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 3 inclusion and 10 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 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?
Crestal ridge width (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.