Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination 70% FDBA and 30% DFDBA, OsteoGen Plug.
- Who it may be relevant to
- Registry conditions: Tooth Extraction. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen®)
Overview
After the removal of a tooth, a bone graft is often placed in the socket to try to keep the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is sometimes kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation including bone allografts (bone grafts derived from a human tissue donor), bone xenografts (bone grafts derived from species other than humans, such as cows and pigs), and synthetic materials that are similar in structure to bone (such as calcium apatite). The bone allograft and the calcium apatite product used in this study are Food and Drug Administration (FDA) approved. This study will compare the two methods used to see how much new bone formation there is inside the tooth socket at about 16 weeks of healing after ridge preservation with a calcium apatite/collagen sponge versus an allograft.
Detailed description
At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.
This will be done by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.
At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with calcium apatite/collagen versus allograft.
The study team will do this by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.
Interventions
- Device Combination 70% FDBA and 30% DFDBA
A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA - Device OsteoGen Plug
A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)
Primary outcome measures
- Percentage of Vital Bone formation [Time frame: 16 weeks]
Secondary outcome measures (2)
- Percentage of Residual Graft Material [Time frame: 16 weeks]
- Percentage of CT/other [Time frame: 16 weeks]
Eligibility criteria
Inclusion criteria
- Male or female patient aged 18 to 89
- One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
- A dental implant is indicated and treatment planned to replace the missing tooth
- Site has adequate restorative space for a dental implant-retained restoration
- Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
- Site has a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and nonpregnant women of child-bearing potential.
- Patients are nonsmokers or former smokers. Current smokers may be included if they smoke <10 cigarettes per day (less than or equal to 10 cigarettes per day)
Exclusion criteria
- Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin
- Patients who will not cooperate with the follow-up schedule.
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected).
- Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
- Smokers who smoke >10 cigarettes per day (more than 10 cigarettes per day)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Texas Health Science Center at San Antonio School of Dentistry — San Antonio
Identifiers
NCT: NCT07154693 · STUDY00001531