Acellular Dermal MatrixNCT07512245
Assessment of Two Soft Tissue Augmentation Using Acellular Dermis Around Dental Implants
A study testing Phase I dental implant placement with acellular dermis and Phase II dental implant uncovery with acellular dermis in people with Acellular Dermal Matrix and Alveolar Mucosa, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This study aims to compare soft tissue grafting with acellular dermis at Phase I or Phase II dental implant surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acellular Dermal Matrix, Alveolar Mucosa
- What is being tested?
- Phase I dental implant placement with acellular dermis and Phase II dental implant uncovery with acellular dermis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- Patients presenting with a single edentulous site planned for dental implant placement deemed deficient in soft tissue peri-implant phenotype (> 2mm width of keratinized tissue, < 1mm marginal soft tissue thickness, and/or > 2mm vertical soft tissue height)
- Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of edentulous site planned for dental implant placement.
- No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.
Who cannot join
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Edentulous sites treatment planned for dental implant placement with adequate implant site soft tissue quality/quantity (> 2mm width of keratinized tissue, > 1mm marginal soft tissue thickness, and/or > 2mm vertical soft tissue height).
- Absence of adjacent teeth/implants on either side of the tooth to be extracted and/or edentulous sites where 2 or more adjacent implants are planned.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
Maria Geisinger, DDS, MS, 205-934-4984, miagdds@uab.edu
Sarah Startley, DMD, 205-975-8711, ss1971@uab.edu
About this study
Official title: Assessment of Two Soft Tissue Augmentation Protocols Using Acellular Dermis for Augmentation of Soft Tissue Quantity and Quality Around Dental Implants
This study aims to compare soft tissue grafting with acellular dermis at Phase I or Phase II dental implant surgery.
Read the detailed description
This proposed study would allow us to assess the use of two different timing protocols for soft tissue augmentation in real-world scenarios to improve clinicians' understanding of optimal protocols for soft tissue grafting and their impact on surgical outcomes, patient-reported outcomes, and long-term implant health.
- Conditions
- Acellular Dermal Matrix, Alveolar Mucosa
- Being tested
- Phase I dental implant placement with acellular dermis, Phase II dental implant uncovery with acellular dermis
- Keywords
- soft tissue graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I dental implant placement with acellular dermisProcedure or surgery
After dental implant placement, soft tissue augmentation using acellular dermis will be performed
Phase II dental implant uncovery with acellular dermisProcedure or surgery
Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed
| Study group | Role | What they receive |
|---|---|---|
| Phase I dental implant placement with acellular dermis | Active comparator | After dental implant placement, soft tissue augmentation using acellular dermis will be performed Receives: Procedure: Phase I dental implant placement with acellular dermis |
| Phase II dental implant uncovery with acellular dermis | Experimental | Dental implant uncovery, soft tissue augmentation using acellular dermis will be performed Receives: Procedure: Phase II dental implant uncovery with acellular dermis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Width of buccal keratinized tissue at dental implant sites
Width of buccal keratinized tissue at dental implant sites as measured with a calibrated UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
Measured: From baseline to 6 months
Thickness of buccal keratinized tissue 2mm from the gingival margin of the dental implant sites
Thickness of buccal keratinized tissue 2mm from the gingival margin as measured with an endodontic reamer with a stopper
Measured: From baseline to 6 months
Vertical height of peri-implant soft tissues
Vertical height of peri-implant soft tissues as measured with an endodontic reamer and stopper after local anesthesia delivery and calibrated periodontal probe from gingival margin to the alveolar crest at the implant sulcus in a parallel manner.
Measured: From Baseline to 6 months
Radiographic marginal bone loss
Radiographic marginal bone loss as measured using digital tool and calibrated parallel radiographic images
Measured: From baseline to 6 months
Patient centered outcomes using the Visual Analog Scale (VAS)
Patient centered outcomes including pain, bleeding, swelling, change in daily activities using the Visual Analog Scale (VAS). This measurement ranges from 0-10 (0 being better and 10 being worse)
Measured: 4 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 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acellular Dermal MatrixStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham
- Investigators
- Maria L Geisinger, DDS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512245
- Sponsor's protocol ID
- IRB-300016380
- Other IDs
- UAB Periodontology
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from this study will not be shared with other researchers outside of our research team.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Two Soft Tissue Augmentation Protocols Using Acellular Dermis for Augmentation of Soft Tissue Quantity and Quality Around Dental Implants
- ClinicalTrials.gov ID
- NCT07512245
- Acronym / sponsor ID
- IRB-300016380
- Conditions
- Acellular Dermal Matrix, Alveolar Mucosa
- Keywords
- soft tissue graft
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 6 Apr 2026 (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.
This study aims to compare soft tissue grafting with acellular dermis at Phase I or Phase II dental implant surgery.
Detailed description
This proposed study would allow us to assess the use of two different timing protocols for soft tissue augmentation in real-world scenarios to improve clinicians' understanding of optimal protocols for soft tissue grafting and their impact on surgical outcomes, patient-reported outcomes, and long-term implant health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase I dental implant placement with acellular dermis | Active comparator | Procedure: Phase I dental implant placement with acellular dermisAfter dental implant placement, soft tissue augmentation using acellular dermis will be performed |
| Phase II dental implant uncovery with acellular dermis | Experimental | Procedure: Phase II dental implant uncovery with acellular dermisDental implant uncovery, soft tissue augmentation using acellular dermis will be performed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- English speaking
- At least 18 years old
- Must be a patient of the UAB Dental School
- Able to read and understand informed consent document
- Patients presenting with a single edentulous site planned for dental implant placement deemed deficient in soft tissue peri-implant phenotype (> 2mm width of keratinized tissue, < 1mm marginal soft tissue thickness, and/or > 2mm vertical soft tissue height)
Key exclusion criteria (6 listed)
- Non-English speaking
- Less than 18 years old
- Smokers/tobacco users (>10 cigarettes/day)
- Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
- Edentulous sites treatment planned for dental implant placement with adequate implant site soft tissue quality/quantity (> 2mm width of keratinized tissue, > 1mm marginal soft tissue thickness, and/or > 2mm vertical soft tissue height).
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 |
|---|---|---|
| Phase I dental implant placement with acellular dermisAfter dental implant placement, soft tissue augmentation using acellular dermis will be performed | Procedure or surgery | Phase I dental implant placement with acellular dermis |
| Phase II dental implant uncovery with acellular dermisDental implant uncovery, soft tissue augmentation using acellular dermis will be performed | Procedure or surgery | Phase II dental implant uncovery with acellular dermis |
Primary outcome
Width of buccal keratinized tissue at dental implant sites
Time frame: From baseline to 6 months
Width of buccal keratinized tissue at dental implant sites as measured with a calibrated UNC-15 periodontal probe from the gingival margin to the mucogingival junction.
Thickness of buccal keratinized tissue 2mm from the gingival margin of the dental implant sites
Time frame: From baseline to 6 months
Thickness of buccal keratinized tissue 2mm from the gingival margin as measured with an endodontic reamer with a stopper
Vertical height of peri-implant soft tissues
Time frame: From Baseline to 6 months
Vertical height of peri-implant soft tissues as measured with an endodontic reamer and stopper after local anesthesia delivery and calibrated periodontal probe from gingival margin to the alveolar crest at the implant sulcus in a parallel manner.
Radiographic marginal bone loss
Time frame: From baseline to 6 months
Radiographic marginal bone loss as measured using digital tool and calibrated parallel radiographic images
Patient centered outcomes using the Visual Analog Scale (VAS)
Time frame: 4 weeks
Patient centered outcomes including pain, bleeding, swelling, change in daily activities using the Visual Analog Scale (VAS). This measurement ranges from 0-10 (0 being better and 10 being worse)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Data from this study will not be shared with other researchers outside of our research team.
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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.
Maria L Geisinger, DDS, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phase I dental implant placement with acellular dermis and Phase II dental implant uncovery with acellular dermis in people with Acellular Dermal Matrix and Alveolar Mucosa, run by University of Alabama at Birmingham 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Geisinger, DDS, MS (205-934-4984, miagdds@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Width of buccal keratinized tissue at dental implant sites (time frame: From baseline to 6 months). The study lists 5 primary outcomes in all. 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 25 Sep 2026.