Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline

NCT06556095 | Completed Early Phase 1 FDA Drug

• 1 other identifier: STUDY00000655
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is 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). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.

Conditions

Bone Graft; Tooth Extraction

Keywords

Allograft; Ridge preservation; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Percentage of Bone Formation

  Difference in percentage of new bone formation at 16 weeks (±2 weeks) after ridge preservation is performed using a combination freeze-dried bone allograft (70% mineralized FDBA:30% demineralized FDBA) that is hydrated for 5 minutes in either sterile saline (control group) or a 4mg/ml dexamethasone solution (test group).

  Baseline to 16 weeks (±2 weeks)

Secondary Outcomes (3)

• Ridge Width

  Baseline to 16 weeks (±2 weeks)

• Buccal Ridge Height

  Baseline to 16 weeks (±2 weeks)

• Lingual Ridge Height

  Baseline to 16 weeks (±2 weeks)

Study Arms (2)

Ridge preservation test group

EXPERIMENTAL

Patients will be randomized to one of the experimental treatment group immediately following tooth extraction and debridement of the socket (test: hydration of allograft with 4mg/1ml dexamethasone solution)

Drug: Dexamethasone 4mg/ml solution

Ridge preservation control group

NO INTERVENTION

Patients will be randomized to the control group immediately following tooth extraction and debridement of the socket (control: hydration of allograft with normal saline solution)

Interventions

Dexamethasone 4mg/ml solution DRUG

The study intervention dexamethasone solution (4mg/ml) is used to hydrate bone allograft.

Also known as: Dexamethasone

Ridge preservation test group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 non-pregnant women of child-bearing potential.
• Patients are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day

You may not qualify if:

• Patient allergic to dexamethasone
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

UT Health Science Center at San Antonio, School of Dentistry

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Dexamethasone; Solutions

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Pharmaceutical Preparations

Study Officials

• Brian L Mealey, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Randomization will be 1:1 so that 22 subjects are enrolled in each group (test and control). Patients will be blind to the hydrating solution used for their bone graft. Histomorphometric examiners will be blinded when the bone cores are evaluated for % vital bone, % residual graft and % CT/other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled clinical trial examining wound healing after tooth extraction and ridge preservation.

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: September 16, 2024
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: At study completion when the results are published in a peer review journal

Locations

US (1)