Recruiting

Calcium Apatite vs. AllograftWound Healing Following Tooth Extraction and Ridge Preservation Using OsteoGen®

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07154693

Conditions

Tooth Extraction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Combination 70% FDBA and 30% DFDBA

OsteoGen Plug

Study Details

Brief summary:

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.

Conditions

Tooth Extraction

Study ID

NCT07154693

Start date

Nov 19, 2025

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Osteogen Test Group

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

active comparator: FDBA/DFDBA Control Group

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product) called "OsteoGen plug®

Interventions

Combination 70% FDBA and 30% DFDBA

A combination freeze-dried bone allograft consisting of 70% mineralized FDBA and 30% demineralized FDBA

OsteoGen Plug

A synthetic calcium apatite material combined with Type 1 bovine collagen (in a sponge-like product)

Primary outcome measure

Percentage of Vital Bone formation [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Brian Mealey, DDS, MS

210-567-3589 mealey@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio School of Dentistry

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Brian L Mealey, DDS, MS

210-567-3318 mealey@uthscsa.edu

Principal Investigator:

Brian L. Mealey, DDS, MS

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jan 6, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-01-06.