Ridge PreservationPhase 4NCT02152215
Ridge Preservation Comparing a Polylactic Acid Membrane vs. an Acellular Dermal Matrix Membrane
A Phase 4 study testing Acellular dermal matrix membrane and Polylactic acid membrane in people with Ridge Preservation, 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 resorbable membranes to determine if either provides a significant therapeutic advantage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ridge Preservation
- What is being tested?
- Acellular dermal matrix membrane and Polylactic acid membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jun 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
- No healthy volunteers
- 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, School of Dentistry, University of Louisville
Louisville, Kentucky, 40202
About this study
Official title: Ridge Preservation Comparing the Clinical and Histologic Healing of a Bioabsorbable Membrane Made of Polylactic Acid and a Citric Acid Ester vs. an Acellular Dermal Matrix Allograft GBR
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and resorbable membranes to determine if either provides a significant therapeutic advantage.
Read the detailed description
The control subjects will receive a bone graft in the extraction socket, plus an additional bone graft on the outside socket wall covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester. The test subjects will receive same type and technique of bone graft with a the acellular dermal matrix membrane to cover the bone graft. The membrane the patients receive will be randomly assigned using a coin toss: heads will be assigned to the test group while tails will be assigned for controls. The objective is to determine if at 4 months the width and height of the jaw bone and also the soft tissue thickness where the tooth was extracted has increased, decreased or remained the same. Also the amount of patients own newly formed bone will be determined by microscopic examination of a core of jaw bone that will be obtained from the site of implant placement immediately before the implant is placed (the implant is not considered part of the study).
- Conditions
- Ridge Preservation
- Being tested
- Acellular dermal matrix membrane, Polylactic acid membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular dermal matrix membraneProcedure or surgery
Also called Alloderm GBR
The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive an intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft covered by an acellular dermal matrix, composed of human connective tissue matrix.
Polylactic acid membraneProcedure or surgery
Also called Guidor
The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft, covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester
| Study group | Role | What they receive |
|---|---|---|
| Acellular dermal matrix membrane | Active comparator | An acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap. Receives: Procedure: Acellular dermal matrix membrane |
| Polylactic acid membrane | Experimental | A polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap. Receives: Procedure: Polylactic acid membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in crestal osseous width
Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
Measured: 4 month
Secondary outcomes (1)
Percent osseous tissue
A trephine core will be harvested at 4 months. Following histologic processing the osseous core will be classified into percent vital bone, nonvital bone and trabecular space.
Measured: 4 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge PreservationStudies 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
- 22 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 School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152215
- Sponsor's protocol ID
- 14.0430
- Status last verified
- Dec 2016
- First submitted
- 21 May 2014
- 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 Bioabsorbable Membrane Made of Polylactic Acid and a Citric Acid Ester vs. an Acellular Dermal Matrix Allograft GBR
- ClinicalTrials.gov ID
- NCT02152215
- Acronym / sponsor ID
- 14.0430
- Conditions
- Ridge Preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and resorbable membranes to determine if either provides a significant therapeutic advantage.
Detailed description
The control subjects will receive a bone graft in the extraction socket, plus an additional bone graft on the outside socket wall covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester. The test subjects will receive same type and technique of bone graft with a the acellular dermal matrix membrane to cover the bone graft. The membrane the patients receive will be randomly assigned using a coin toss: heads will be assigned to the test group while tails will be assigned for controls. The objective is to determine if at 4 months the width and height of the jaw bone and also the soft tissue thickness where the tooth was extracted has increased, decreased or remained the same. Also the amount of patients own newly formed bone will be determined by microscopic examination of a core of jaw bone that will be obtained from the site of implant placement immediately before the implant is placed (the implant is not considered part of the study).
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 membrane | Active comparator | Procedure: Acellular dermal matrix membraneAn acellular dermal matrix membrane will be used as a barrier between the osseous graft and the soft tissue flap. |
| Polylactic acid membrane | Experimental | Procedure: Polylactic acid membraneA polylactic acid membrane will be used as a barrier between the osseous graft and the soft tissue flap. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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 |
|---|---|---|
| Acellular dermal matrix membraneAlso: Alloderm GBRThe surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive an intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft covered by an acellular dermal matrix, composed of human connective tissue matrix. | Procedure or surgery | Acellular dermal matrix membrane |
| Polylactic acid membraneAlso: GuidorThe surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft, covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester | Procedure or surgery | Polylactic acid membrane |
Primary outcome
Change in crestal osseous width
Time frame: 4 month
Horizontal post-extraction ridge measurements at the mid-defect alveolar crest and 5 mm apical taken with a caliper.
1 secondary outcome
Percent osseous tissue
Time frame: 4 months post-treatment
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.
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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.
Henry Greenwell, DMD, MSD principal investigator
University of Louisville School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acellular dermal matrix membrane and Polylactic acid membrane in people with Ridge Preservation, 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.
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?
Change in crestal osseous width (time frame: 4 month). 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 31 Oct 2026.