Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft

May 23, 2023 updated by: The University of Texas Health Science Center at San Antonio

Randomized Controlled Trial of Wound Healing Following Tooth Extraction and Ridge Preservation Using Decalcified Freeze-dried Bone Allograft (DFDBA) Alone in Particulate Fiber Form and in Combination With Xenograft

The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % "CT/other" (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio (Dental School)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Brian L Mealey, DDS, MS
        • Principal Investigator:
          • Angela Palaiologou-Gallis Palaiologou-Gallis, DDS

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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
  • Have adequate restorative space for a dental implant-retained restoration
  • Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
  • Have 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.
  • Are nonsmokers or former smokers. Current smokers may be included if they smoke <10 cigarettes per day

Exclusion Criteria:

  • 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
  • Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 Vallos
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Device: Vallos
Demineralized freeze-dried bone allograft (DFBA) in a small particle form
Other Names:
  • DFDBA particulate
Active Comparator: Group 2 Vallomix
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Device: Vallomix
A combination of cow-derived xenograft and human-derived DFDBA particulate
Other Names:
  • Xenograft and human-derived DFDBA
Active Comparator: Group 3 Vallos-F
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Device: Vallos-F
Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
Other Names:
  • DFDBA in fiber form
Active Comparator: Group 4 Vallomix-F
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.
Device: Vallomix-F
A combination of cow-derived xenograft and human-derived DFDBA fibers
Other Names:
  • Xenograft (Bio-Oss) combined with DFDBA fibers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage vital bone formation
Time Frame: Wound healing time ( approximately 18 to 20 weeks)
Measure of percentage of vital bone formation from extraction to time of implant
Wound healing time ( approximately 18 to 20 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of residual graft material
Time Frame: Wound healing time ( approximately 18 to 20 weeks)
Measure of percentage of residual graft material remaining at time of implant
Wound healing time ( approximately 18 to 20 weeks)
Percentage of connective tissue
Time Frame: Wound healing time ( approximately 18 to 20 weeks)
Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant.
Wound healing time ( approximately 18 to 20 weeks)
Change in ridge width
Time Frame: Baseline to 18-20 weeks
Measure of change in ridge width from extraction to healing time
Baseline to 18-20 weeks
Change in buccal ridge height
Time Frame: Baseline to 18-20 weeks
Measure of change in buccal ridge height from extraction to healing time
Baseline to 18-20 weeks
Change in lingual ridge height
Time Frame: Baseline to 18-20 weeks
Measure of change in lingual ridge height from extraction to healing time
Baseline to 18-20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Brian Mealey, DDS, MS, University of Texas Health Science Center San Antonio
  • Principal Investigator: Angela Palaiologou-Gallis, DDS, University of Texas Health Science Center 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 Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Anticipated)

March 31, 2025

Study Completion (Anticipated)

March 31, 2025

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC20220346H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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