Actively Recruiting
Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen)
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-01-06
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating new bone growth inside the tooth socket about 16 weeks after ridge preservation following tooth extraction. The study compares two methods: using a synthetic calcium apatite material with bovine collagen (OsteoGen plug) versus a bone allograft made from human donor bone. Both materials are approved by the Food and Drug Administration. This study aims to understand which method better supports bone healing needed for dental implant placement. Participants will receive ridge preservation treatment after tooth removal using either the OsteoGen plug or a combination of freeze-dried bone allografts. The procedure involves placing the bone graft material into the tooth socket to maintain bone volume and prevent shrinkage. The bone samples needed for analysis will be collected during the standard implant placement visit around 16 weeks after the grafting procedure. During the study, participants will undergo scheduled visits including the implant placement at about 16 weeks post-treatment when bone samples will be collected for analysis. Researchers will measure the percentage of new vital bone formation inside the tooth socket to compare the two materials. The study includes safety monitoring and follow-up to assess healing and treatment outcomes. Total participation lasts through the implant placement period and associated evaluations.
CONDITIONS
Brief Title
Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patient aged 18 to 89
- One tooth, excluding molars, identified as needing single tooth extraction
- Dental implant planned to replace the missing tooth
- Adequate restorative space for dental implant-retained restoration
- At least 10mm of alveolar bone height without impinging on sinus or nerve canal
- Buccal or lingual bony plate dehiscence extending no more than 50% of socket depth
- Female patients who have had hysterectomy, tubal ligation, menopause, or nonpregnant women of child-bearing potential
- Nonsmokers, former smokers, or current smokers smoking 10 or fewer cigarettes per day
You will not qualify if you...
- Allergy to bovine-derived collagen products, Bacitracin, Gentamicin, or Polymyxin
- Inability or unwillingness to comply with follow-up schedule
- Mentally incompetent individuals, prisoners, or pregnant women
- Pregnant women or women intending to become pregnant during the study period
- Smokers who smoke more than 10 cigarettes per day
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 16 weeks
Participants undergo tooth extraction followed by ridge preservation using either the OsteoGen plug or a bone allograft combination as part of their dental implant preparation.
Multiple visits for treatment and assessment over 16 weeks
Duration - Up to approximately 16 weeks
Participants are monitored after ridge preservation to assess bone healing and new bone formation in the tooth socket.
Follow-up visits leading up to implant placement visit
Trial Site Locations
Total: 1 location
1
University of Texas Health Science Center at San Antonio School of Dentistry
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
B
Brian Mealey, DDS, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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