Biotivity A/C Plus Membrane for Alveolar Ridge Preservation after Tooth Extraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, controlled pilot trial comparing Biotivity A/C Plus Membrane to a conventional collagen membrane for alveolar ridge preservation after atraumatic extraction of a posterior tooth. Participants receive bone graft material and membranes, followed by implant placement after about five months. Primary outcome focuses on soft tissue wound healing; secondary outcomes include changes in hard and soft tissue dimensions, histology of new bone, and implant placement feasibility. The study runs over approximately six months with nine visits, including screening, ARP surgery, post-operative follow-ups, and implant re-entry. Conducted at the University of Maryland School of Dentistry, it aims to determine if the amnion chorion membrane provides superior outcomes compared with standard care.

Why it matters

Who can join: the full rules

Inclusion criteria:

1. Provision of informed consent
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

1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
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.

Where it's running

• University of Maryland School of Dentistry
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Hanae Saito, DDS MS CCRC — University of Maryland School of Dentistry
• Study coordinator: Hanae Saito, DDS MS CCRC
• Email: hsaito@umaryland.edu
• Phone: 410-706-3646

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing new bone graft materials for preserving jawbone after tooth extraction

  This study is testing a new bone graft material to see if it can better preserve jawbone after tooth extractions compared to a standard option, helping people who need implants in the future.

  Recruiting Nova Southeastern University · Fort Lauderdale, Florida · NCT06275789

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.