Wound HealNCT05802602
Porcine Membrane vs Bovine Wound Dressing in Human Tooth Extraction Sites
A study testing Porcine Collagen Membrane and Bovine Collagen Dressing in people with Wound Heal, run by University of Nebraska at 1 site in United States.
Trial summary
The purpose of this study is to compare porcine collagen membrane and bovine collagen wound dressing in human tooth extraction sites. The outcomes measured will be soft tissue thickness changes as well as bone density changes. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal
- What is being tested?
- Porcine Collagen Membrane and Bovine Collagen Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2023to 30 Nov 2025
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smoking
- Aged 19-65
- Requiring premolar or anterior tooth extraction and graft procedures
- Good general health
- Willing to provide informed consent.
Who cannot join
- History of radiation therapy or bisphosphonate use
- Pregnancy or breastfeeding
- Systemic conditions that affect bone healing
- Contraindications to dental implants
- Inability to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center, College of Dentistry
Lincoln, Nebraska, 68503
About this study
Official title: Comparison of Porcine Collagen Membrane and Bovine Collagen Wound Dressing in Human Extraction Sites With DFDBA Graft: A Randomized Controlled Trial
The purpose of this study is to compare porcine collagen membrane and bovine collagen wound dressing in human tooth extraction sites. The outcomes measured will be soft tissue thickness changes as well as bone density changes.
Read the detailed description
The purpose of this study is to compare the effectiveness of a porcine collagen membrane to a bovine collagen wound dressing for atraumatic extractions. These are both commonly used as a barrier and containment material over atraumatic extraction sites that are grafted for future implant placement. The study will include nonsmoking adults aged 18-65 requiring premolar or anterior tooth extraction and graft procedures, who are in good general health and willing to provide informed consent. Exclusion criteria include a history of radiation therapy or bisphosphonate use, pregnancy or breastfeeding, systemic conditions that affect bone healing, contraindications to dental implants, and inability to attend follow-up visits. The study will be a double-blind randomized controlled trial involving 24 patients who will be assigned to two groups. Prior to tooth extraction, baseline data will be collected; including gingival crevicular fluid (GCF) sampling, and a limited field Cone Beam Computed Tomography (CBCT) radiograph. A reference digital scan will be taken to measure volumetric changes in soft tissue. Routine, atraumatic extraction of the tooth under local anesthetic will be performed. Following extraction, hydrated AllOss 50/50 DFDBA:FDBA (demineralized freeze-dried bone allograft:freeze-dried bone allograft) bone particulate will be condensed following a routine protocol. One group will receive Mucograft Seal over the graft, and the other group will receive Integra HeliPlug. Patients will be seen at a standard 2-week follow up to remove sutures, have a GCF sampling at the adjacent teeth and take another digital scan. Patients will be seen for an additional 6-week follow up to take a small (2mm) incisional biopsy for histological analysis. Another digital scan and GCF sampling will be taken. Final evaluation will be 3 months post-extraction and will include a localized CBCT evaluation for implant planning and another measure of soft tissue changes with a digital scan. At the time of implant surgery, the core of bone removed during osteotomy will be histologically analyzed for percentage of vital bone. Adverse events will also be recorded at each visit. The primary outcome measure will be the histological composition of tissue at 6 weeks and volumetric tissue changes. The secondary outcome measures will be bone density changes on the post-operative CBCT and inflammatory bio-markers present at baseline, 2-weeks via GCF sampling.
- Conditions
- Wound Heal
- Being tested
- Porcine Collagen Membrane, Bovine Collagen Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine Collagen MembraneDevice
Also called Mucograft
Atraumatic tooth extraction with porcine collagen membrane placement
Bovine Collagen DressingDevice
Also called Heliplug
Atraumatic tooth extraction with bovine collagen dressing placement
| Study group | Role | What they receive |
|---|---|---|
| Porcine Collagen Membrane | Experimental | Atraumatic tooth extraction with porcine collagen membrane placement Receives: Device: Porcine Collagen Membrane |
| Bovine Collagen Dressing | Active comparator | Atraumatic tooth extraction with bovine collagen dressing placement Receives: Device: Bovine Collagen Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Thickness in mm
Soft tissue biopsy to determine tissue thickness, measured in mm
Measured: 6 weeks
Secondary outcomes (2)
Bone Density Measurements
Bone density measurements to assess vital bone, bone tissue that retains living cells and a blood supply, at the extraction site CBCT measurement of bone density at baseline and three months, measured in Hounsfield units
Measured: Baseline, 3 Months
Interleukin-1beta
Interleukin-1beta (IL-1β), a pro-inflammatory cytokine primarily produced by immune cells and measured in pg/mL, will be assessed from gingival crevicular fluid (GCF) samples around the extraction site taken at baseline, 2 weeks and 6 weeks.
Measured: Baseline, 2 Weeks & 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start16 Apr 2023
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy C Killeen, DDS, MS, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802602
- Sponsor's protocol ID
- 0145-23-FB
- Status last verified
- May 2025
- First submitted
- 2 Mar 2023
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Porcine Collagen Membrane and Bovine Collagen Wound Dressing in Human Extraction Sites With DFDBA Graft: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05802602
- Acronym / sponsor ID
- 0145-23-FB
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 16 Apr 2023 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 6 Apr 2023 (actual)
- 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 porcine collagen membrane and bovine collagen wound dressing in human tooth extraction sites. The outcomes measured will be soft tissue thickness changes as well as bone density changes.
Detailed description
The purpose of this study is to compare the effectiveness of a porcine collagen membrane to a bovine collagen wound dressing for atraumatic extractions. These are both commonly used as a barrier and containment material over atraumatic extraction sites that are grafted for future implant placement. The study will include nonsmoking adults aged 18-65 requiring premolar or anterior tooth extraction and graft procedures, who are in good general health and willing to provide informed consent. Exclusion criteria include a history of radiation therapy or bisphosphonate use, pregnancy or breastfeeding, systemic conditions that affect bone healing, contraindications to dental implants, and inability to attend follow-up visits. The study will be a double-blind randomized controlled trial involving 24 patients who will be assigned to two groups. Prior to tooth extraction, baseline data will be collected; including gingival crevicular fluid (GCF) sampling, and a limited field Cone Beam Computed Tomography (CBCT) radiograph. A reference digital scan will be taken to measure volumetric changes in soft tissue. Routine, atraumatic extraction of the tooth under local anesthetic will be performed. Following extraction, hydrated AllOss 50/50 DFDBA:FDBA (demineralized freeze-dried bone allograft:freeze-dried bone allograft) bone particulate will be condensed following a routine protocol. One group will receive Mucograft Seal over the graft, and the other group will receive Integra HeliPlug. Patients will be seen at a standard 2-week follow up to remove sutures, have a GCF sampling at the adjacent teeth and take another digital scan. Patients will be seen for an additional 6-week follow up to take a small (2mm) incisional biopsy for histological analysis. Another digital scan and GCF sampling will be taken. Final evaluation will be 3 months post-extraction and will include a localized CBCT evaluation for implant planning and another measure of soft tissue changes with a digital scan. At the time of implant surgery, the core of bone removed during osteotomy will be histologically analyzed for percentage of vital bone. Adverse events will also be recorded at each visit. The primary outcome measure will be the histological composition of tissue at 6 weeks and volumetric tissue changes. The secondary outcome measures will be bone density changes on the post-operative CBCT and inflammatory bio-markers present at baseline, 2-weeks via GCF sampling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Porcine Collagen Membrane | Experimental | Device: Porcine Collagen MembraneAtraumatic tooth extraction with porcine collagen membrane placement |
| Bovine Collagen Dressing | Active comparator | Device: Bovine Collagen DressingAtraumatic tooth extraction with bovine collagen dressing placement |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smoking
- Aged 19-65
- Requiring premolar or anterior tooth extraction and graft procedures
- Good general health
- Willing to provide informed consent.
Key exclusion criteria (5 listed)
- History of radiation therapy or bisphosphonate use
- Pregnancy or breastfeeding
- Systemic conditions that affect bone healing
- Contraindications to dental implants
- Inability to attend follow-up visits.
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 |
|---|---|---|
| Porcine Collagen MembraneAlso: MucograftAtraumatic tooth extraction with porcine collagen membrane placement | Device | Porcine Collagen Membrane |
| Bovine Collagen DressingAlso: HeliplugAtraumatic tooth extraction with bovine collagen dressing placement | Device | Bovine Collagen Dressing |
Primary outcome
Soft Tissue Thickness in mm
Time frame: 6 weeks
Soft tissue biopsy to determine tissue thickness, measured in mm
2 secondary outcomes
Bone Density Measurements
Time frame: Baseline, 3 Months
Interleukin-1beta
Time frame: Baseline, 2 Weeks & 6 Weeks
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 11 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Amy C Killeen, DDS, MS principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine Collagen Membrane and Bovine Collagen Dressing in people with Wound Heal, run by University of Nebraska 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 5 inclusion and 5 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 11 Feb 2026. 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 in mm (time frame: 6 weeks). 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 11 Feb 2026.