Alveolar Ridge PreservationPhase 4NCT07091448
Biotivity A-C Membrane Socket Preservation Study
A Phase 4 study testing Amnion chorion membrane and Collagen membrane in people with Alveolar Ridge Preservation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. 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 Preservation
- What is being tested?
- Amnion chorion membrane and Collagen membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 31 Oct 2028
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- At least 18 years old
- In need of one posterior tooth (premolar or molar), excluding third molars, planned for extraction and replacement with a dental implant
- Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
- At least one retained natural tooth adjacent to the study site
Who cannot join
- Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
- Previous interventions performed involving soft and/or bone grafting in the study site
- Active caries
- Uncontrolled periodontal disease present
- Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
- History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
Show all 12Show fewer
- Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
- Self-reported use of smokeless tobacco or e-cigarette
- Self-reported history of current alcohol or drug abuse
- Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c > 8.0 within last six-month13,14
- Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
- Pregnancy, as confirmed by a urine pregnancy test at screening.
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, 1 recruiting
- Recruiting
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
Hanae Saito, DDS MS CCRC, 410-706-3646, hsaito@umaryland.edu
Hanae Saito, DDS MS CCRC
About this study
Official title: Prospective, Assessment of Alveolar Ridge Preservation Using Biotivity™ Amnion Chorion Membranein Atraumatic Extraction Socket
This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. A total of 12 subjects will be enrolled at the University of Maryland School of Dentistry. The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement.
Throughout the approximately 6-month study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material and barrier placement, and dental implant placement.
Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.
Read the detailed description
This randomized, controlled, parallel-arm clinical study investigates the use of Biotivity™ A/C Plus Membrane, a bioactive human amnion chorion-derived barrier membrane, in alveolar ridge preservation (ARP) of Type I or II extraction sockets. Subjects will be randomized to receive either the investigational amnion chorion membrane or a conventional collagen membrane (CopiOs Extend) over cancellous allograft (Puros®) after flapless tooth extraction in the premolar or molar region (excluding third molars).
The study will evaluate:
Primary outcome: soft tissue wound healing over 5 months using standardized wound healing indices.
Secondary outcomes: hard and soft tissue dimensional changes using CBCT and intraoral scanning, histologic evaluation of new bone formation, and implant placement feasibility.
Subjects will be followed across nine visits, including baseline (screening), ARP surgery, post-operative evaluations at multiple time points, and re-entry for implant placement at 5 months. The final implant-supported restoration will be delivered after implant integration, with continued follow-up for histologic and radiographic outcomes.
This study aims to determine whether the amnion chorion membrane provides superior soft tissue healing and volumetric bone preservation compared to conventional membranes in ARP procedures, with the goal of improving clinical outcomes in implant dentistry.
- Conditions
- Alveolar Ridge Preservation
- Being tested
- Amnion chorion membrane, Collagen membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion chorion membraneDevice
Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.
Collagen membraneDevice
Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..
| Study group | Role | What they receive |
|---|---|---|
| Alveolar ridge preservation with amnion chorion membrane | Experimental | The patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called Biotivity™ A-C Plus. Receives: Device: Amnion chorion membrane |
| Alveolar ridge preservation with collagen membrane | Active comparator | The patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called CopiOs. Receives: Device: Collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft Tissue Wound Healing Score Using Wound Healing Indices
Wound healing will be assessed during post-surgery follow-up visits using the Early Wound Healing Index (Wachtel et al., 2003), which classifies flap closure into five categories (1 = complete closure, no fibrin; 5 = necrosis), and Wound Healing Index (WHI) described by Huang (2025 ) with three categories (1 = uneventful healing with no gingival edema, erythema, suppuration, patient dis-comfort, or flap dehiscence; 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.) Scores will be assigned by a blinded examiner. Data will be reported as the number of participants per score category and the median EHI score per treatment group.
Measured: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 5-month dental implant placement [Visit6].
Secondary outcomes (2)
Radiographic measurement of Mean Change at 4 Months Measured by CBCT
Vertical and volumetric changes in alveolar ridge dimensions will be assessed using cone-beam computed tomography (CBCT) taken at baseline (post-extraction) and 4 months after alveolar ridge preservation.
Vertical bone height will be measured at the mid-buccal point from the cementoenamel junction (CEJ) to the alveolar crest.
Volumetric bone change will be calculated at 1 mm, 3 mm, and 5 mm apical to the alveolar crest using cross-sectional slices and 3D analysis software (Geomagic Control X).
Data will be reported as mean change (mm for height; mm³ for volume) and standard deviation per group.
Measured: Over the course of the study (4 months, From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 6-month dental implant placement [Visit 9]).
Soft Tissue Change from Baseline to 4 Months Using Intraoral Scans
Buccal soft tissue thickness will be evaluated using superimposed STL files obtained from intraoral digital scans. Scans will be collected at baseline, immediate post-surgery and 4 month post-surgery. Thickness will be measured at the mid-buccal point of the site, and changes will be reported as mean (mm) per group.
Measured: Over the course of the study (4 months, From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 6-month dental implant placement [Visit 9]).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Sep 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanae Saito, DDS MS CCRC, Principal investigator, University of Maryland School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091448
- Sponsor's protocol ID
- HP-00114841
- Status last verified
- Oct 2026
- First submitted
- 24 Jun 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Assessment of Alveolar Ridge Preservation Using Biotivity™ Amnion Chorion Membranein Atraumatic Extraction Socket
- ClinicalTrials.gov ID
- NCT07091448
- Acronym / sponsor ID
- HP-00114841
- Conditions
- Alveolar Ridge Preservation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 29 Jul 2025 (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 is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. A total of 12 subjects will be enrolled at the University of Maryland School of Dentistry. The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement.
Throughout the approximately 6-month study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material and barrier placement, and dental implant placement.
Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.
Detailed description
This randomized, controlled, parallel-arm clinical study investigates the use of Biotivity™ A/C Plus Membrane, a bioactive human amnion chorion-derived barrier membrane, in alveolar ridge preservation (ARP) of Type I or II extraction sockets. Subjects will be randomized to receive either the investigational amnion chorion membrane or a conventional collagen membrane (CopiOs Extend) over cancellous allograft (Puros®) after flapless tooth extraction in the premolar or molar region (excluding third molars).
The study will evaluate:
Primary outcome: soft tissue wound healing over 5 months using standardized wound healing indices.
Secondary outcomes: hard and soft tissue dimensional changes using CBCT and intraoral scanning, histologic evaluation of new bone formation, and implant placement feasibility.
Subjects will be followed across nine visits, including baseline (screening), ARP surgery, post-operative evaluations at multiple time points, and re-entry for implant placement at 5 months. The final implant-supported restoration will be delivered after implant integration, with continued follow-up for histologic and radiographic outcomes.
This study aims to determine whether the amnion chorion membrane provides superior soft tissue healing and volumetric bone preservation compared to conventional membranes in ARP procedures, with the goal of improving clinical outcomes in implant dentistry.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alveolar ridge preservation with amnion chorion membrane | Experimental | Device: Amnion chorion membraneThe patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called Biotivity™ A-C Plus. |
| Alveolar ridge preservation with collagen membrane | Active comparator | Device: Collagen membraneThe patients in both groups will go through the same treatment but with two different barrier membrane depending on the assigned group. The patients in this group will have alveolar ridge preservation with the amnion chorion membrane called CopiOs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent
- At least 18 years old
- In need of one posterior tooth (premolar or molar), excluding third molars, planned for extraction and replacement with a dental implant
- Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
- At least one retained natural tooth adjacent to the study site
Key exclusion criteria (12 listed)
- Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
- Previous interventions performed involving soft and/or bone grafting in the study site
- Active caries
- Uncontrolled periodontal disease present
- Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
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 |
|---|---|---|
| Amnion chorion membraneAlveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus. | Device | Alveolar ridge preservation with amnion chorion membrane |
| Collagen membraneAlveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs.. | Device | Alveolar ridge preservation with collagen membrane |
Primary outcome
Soft Tissue Wound Healing Score Using Wound Healing Indices
Time frame: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 5-month dental implant placement [Visit6].
Wound healing will be assessed during post-surgery follow-up visits using the Early Wound Healing Index (Wachtel et al., 2003), which classifies flap closure into five categories (1 = complete closure, no fibrin; 5 = necrosis), and Wound Healing Index (WHI) described by Huang (2025 ) with three categories (1 = uneventful healing with no gingival edema, erythema, suppuration, patient dis-comfort, or flap dehiscence; 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence, but no suppuration; 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.) Scores will be assigned by a blinded examiner. Data will be reported as the number of participants per score category and the median EHI score per treatment group.
2 secondary outcomes
Radiographic measurement of Mean Change at 4 Months Measured by CBCT
Time frame: Over the course of the study (4 months, From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 6-month dental implant placement [Visit 9]).
Soft Tissue Change from Baseline to 4 Months Using Intraoral Scans
Time frame: Over the course of the study (4 months, From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 6-month dental implant placement [Visit 9]).
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 9 Oct 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.
Hanae Saito, DDS MS CCRC principal investigator
University of Maryland 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 Amnion chorion membrane and Collagen membrane in people with Alveolar Ridge Preservation, run by University of Maryland, Baltimore 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 12 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: looking for participants now, as of the sponsor's last update on 9 Oct 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.
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?
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 Hanae Saito, DDS MS CCRC (410-706-3646, hsaito@umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Soft Tissue Wound Healing Score Using Wound Healing Indices (time frame: Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 5-month dental implant placement [Visit6].). 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 9 Oct 2026.