RECRUITING

Wound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-09-01
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07154693

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patient aged 18 to 89
  2. * One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
  3. * A dental implant is indicated and treatment planned to replace the missing tooth
  4. * Site has adequate restorative space for a dental implant-retained restoration
  5. * Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
  6. * 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.
  7. * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and nonpregnant women of child-bearing potential.
  8. * 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)
  1. * Patient allergic to bovine-derived collagen products, Bacitracin, Gentamicin, Polymyxin
  2. * Patients who will not cooperate with the follow-up schedule.
  3. * Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
  4. * 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).
  5. * Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
  6. * Smokers who smoke \>10 cigarettes per day (more than 10 cigarettes per day)

Contacts and Locations

Study Contact

Brian Mealey, DDS, MS
CONTACT
210-567-3589
mealey@uthscsa.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-01
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2025-09-01
Study Completion Date2027-12-31

Terms related to this study

Keywords Provided by Researchers

  • Wound healing
  • Vital bone
  • Mineralized freeze-dried bone allograft (FDBA)
  • Demineralized freeze-dried bone allograft (DFDBA)
  • Ridge preservation

Additional Relevant MeSH Terms

  • Tooth Extraction