Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
12 participants
INTERVENTIONAL
2026-04-01
2028-10-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alveolar ridge preservation with amnion chorion membrane
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.
Amnion chorion membrane
Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.
Alveolar ridge preservation with collagen membrane
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.
Collagen membrane
Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..
Interventions
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Amnion chorion membrane
Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.
Collagen membrane
Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..
Eligibility Criteria
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Inclusion Criteria
2. At least 18 years old
3. In need of one posterior tooth (premolar or molar), excluding third molars, planned for extraction and replacement with a dental implant
4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
5. At least one retained natural tooth adjacent to the study site
Exclusion Criteria
2. Previous interventions performed involving soft and/or bone grafting in the study site
3. Active caries
4. Uncontrolled periodontal disease present
5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
8. Self-reported use of smokeless tobacco or e-cigarette
9. Self-reported history of current alcohol or drug abuse
10. 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
11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
12. Pregnancy, as confirmed by a urine pregnancy test at screening.
18 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Principal Investigators
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Hanae Saito, DDS MS CCRC
Role: PRINCIPAL_INVESTIGATOR
University of Maryland School of Dentistry
Locations
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University of Maryland School of Dentistry
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HP-00114841
Identifier Type: -
Identifier Source: org_study_id
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