RECRUITING

Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Description

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.

Study Overview

Study Details

Study 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.

Wound Healing Following Tooth Extraction and Ridge Preservation Using Resorbable Non-ceramic Calcium Apatite Granules in Type I Bovine Collagen Plugs (OsteoGen®)

Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Condition
Tooth Extraction
Intervention / Treatment

-

Contacts and Locations

San Antonio

University of Texas Health Science Center at San Antonio School of Dentistry, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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)

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

The University of Texas Health Science Center at San Antonio,

Brian Mealey, DDS, MS, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center at San Antonio

Study Record Dates

2027-12-31