Clinical EfficacyNCT01902056
Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix
A study testing One layer allograft and Two layer allograft in people with Clinical Efficacy, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Efficacy
- What is being tested?
- One layer allograft and Two layer allograft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2013
- 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
- one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
- at least 18 years of age
- must sign the informed consent -
Who cannot join
- uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
- previous head and neck radiation
- oral bisphosphonates for > 3 years or any IV bisphosphonates
- smoking > 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
- requirement for prophylactic antibiotics
- allergies to any medication or material used in the study, or that would adversely affect study procedures
Show all 10Show fewer
- chemotherapy in the previous 12 months
- psychological problems that would interfere with treatment
- patients unable or unwilling to sign the informed consent
- pregnancy -
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: Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.
The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.
Read the detailed description
Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.
- Conditions
- Clinical Efficacy
- Being tested
- One layer allograft, Two layer allograft
- Keywords
- allograft, acellular dermal matrix, Alloderm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One layer allograftProcedure or surgery
Also called One layer of acellular dermal matrix (Alloderm).
The acellular dermal matrix was placed on the facial surface.
Two layer allograftProcedure or surgery
Also called Two layers of acellular dermal matrix (Alloderm).
The acellular dermal matrix was placed on the facial surface.
| Study group | Role | What they receive |
|---|---|---|
| one layer allograft | Active comparator | One layer allograft as a positive control Receives: Procedure: One layer allograft |
| Two layer allograft | Experimental | Two layer allograft as the test group. Receives: Procedure: Two layer allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue thickness.
Determining the soft tissue thickness using a tissue probe.
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 posted17 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical EfficacyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 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
- NCT01902056
- Sponsor's protocol ID
- 12.0330
- Status last verified
- Jul 2013
- First submitted
- 7 Jul 2013
- Last updated
- 17 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.
- ClinicalTrials.gov ID
- NCT01902056
- Acronym / sponsor ID
- 12.0330
- Conditions
- Clinical Efficacy
- Keywords
- allograft, acellular dermal matrix, Alloderm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 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 effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.
Detailed description
Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one layer allograft | Active comparator | Procedure: One layer allograftOne layer allograft as a positive control |
| Two layer allograft | Experimental | Procedure: Two layer allograftTwo layer allograft as the test group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
- at least 18 years of age
- must sign the informed consent -
Key exclusion criteria (10 listed)
- uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
- previous head and neck radiation
- oral bisphosphonates for > 3 years or any IV bisphosphonates
- smoking > 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
- requirement for prophylactic antibiotics
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 |
|---|---|---|
| One layer allograftAlso: One layer of acellular dermal matrix (Alloderm).The acellular dermal matrix was placed on the facial surface. | Procedure or surgery | one layer allograft |
| Two layer allograftAlso: Two layers of acellular dermal matrix (Alloderm).The acellular dermal matrix was placed on the facial surface. | Procedure or surgery | Two layer allograft |
Primary outcome
Soft tissue thickness.
Time frame: 4 months
Determining the soft tissue thickness using a tissue probe.
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 17 Jul 2013.
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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 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 One layer allograft and Two layer allograft in people with Clinical Efficacy, 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 17 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?
Soft tissue thickness. (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 17 Jul 2013.