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Biotivity A-C Membrane Socket Preservation Study

ConditionAlveolar Ridge Preservation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amnion chorion membrane

    Device

    Alveolar ridge preservation of a single extraction socket site with a barrier membrane Biotivity™ A/C Plus.

  • Collagen membrane

    Device

    Alveolar ridge preservation of a single extraction socket site with a barrier membrane CopiOs..

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Alveolar ridge preservation with amnion chorion membraneExperimental treatment 1 intervention
Group B: Alveolar ridge preservation with collagen membraneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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].

Secondary outcomes

1

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.

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]).
2

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.

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]).

Other outcomes

Sponsors and contacts

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University of Maryland, Baltimore

Lead sponsor

Source ClinicalTrials.gov
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