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

Primary Purpose

Dental Extraction, Wound Heal

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vallos

Vallomix

Vallos-F

Vallomix-F

About this trial

This is an interventional treatment trial for Dental Extraction focused on measuring Ridge preservation, Implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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Patients who become pregnant during the study will be withdrawn and standard care will be delivered.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.

Sites / Locations

University of Texas Health Science Center at San Antonio (Dental School)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Group 1 Vallos

Group 2 Vallomix

Group 3 Vallos-F

Group 4 Vallomix-F

Arm Description

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Outcomes

Primary Outcome Measures

Percentage vital bone formation

Measure of percentage of vital bone formation from extraction to time of implant

Secondary Outcome Measures

Percentage of residual graft material

Measure of percentage of residual graft material remaining at time of implant

Percentage of connective tissue

Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant.

Change in ridge width

Measure of change in ridge width from extraction to healing time

Change in buccal ridge height

Measure of change in buccal ridge height from extraction to healing time

Change in lingual ridge height

Measure of change in lingual ridge height from extraction to healing time

Full Information

NCT ID

NCT05400213

First Posted

May 26, 2022

Last Updated

May 23, 2023

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT05400213

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 2, 2022 (Actual)

Primary Completion Date

March 31, 2025 (Anticipated)

Study Completion Date

March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Extraction, Wound Heal

Keywords

Ridge preservation, Implant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

4 arm randomized controlled parallel study

Masking

Outcomes Assessor

Masking Description

Since the outcome of the study is the histologic healing, blinding of the surgeon is not necessary. Blinding is performed only for histomorphometric measurements. The person doing histomorphometric analysis is blinded as to study group.

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 Vallos

Arm Type

Active Comparator

Arm Description

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Arm Title

Group 2 Vallomix

Arm Type

Active Comparator

Arm Description

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Arm Title

Group 3 Vallos-F

Arm Type

Active Comparator

Arm Description

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Arm Title

Group 4 Vallomix-F

Arm Type

Active Comparator

Arm Description

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Intervention Type

Device

Intervention Name(s)

Vallos

Other Intervention Name(s)

DFDBA particulate

Intervention Description

Demineralized freeze-dried bone allograft (DFBA) in a small particle form

Intervention Type

Device

Intervention Name(s)

Vallomix

Other Intervention Name(s)

Xenograft and human-derived DFDBA

Intervention Description

A combination of cow-derived xenograft and human-derived DFDBA particulate

Intervention Type

Device

Intervention Name(s)

Vallos-F

Other Intervention Name(s)

DFDBA in fiber form

Intervention Description

Demineralized freeze-dried bone allograft (DFDBA) in a fiber form

Intervention Type

Device

Intervention Name(s)

Vallomix-F

Other Intervention Name(s)

Xenograft (Bio-Oss) combined with DFDBA fibers

Intervention Description

A combination of cow-derived xenograft and human-derived DFDBA fibers

Primary Outcome Measure Information:

Title

Percentage vital bone formation

Description

Measure of percentage of vital bone formation from extraction to time of implant

Time Frame

Wound healing time ( approximately 18 to 20 weeks)

Secondary Outcome Measure Information:

Title

Percentage of residual graft material

Description

Measure of percentage of residual graft material remaining at time of implant

Time Frame

Wound healing time ( approximately 18 to 20 weeks)

Title

Percentage of connective tissue

Description

Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant.

Time Frame

Wound healing time ( approximately 18 to 20 weeks)

Title

Change in ridge width

Description

Measure of change in ridge width from extraction to healing time

Time Frame

Baseline to 18-20 weeks

Title

Change in buccal ridge height

Description

Measure of change in buccal ridge height from extraction to healing time

Time Frame

Baseline to 18-20 weeks

Title

Change in lingual ridge height

Description

Measure of change in lingual ridge height from extraction to healing time

Time Frame

Baseline to 18-20 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Brian Mealey, DDS, MS

Phone

210-567-3589

mealey@uthscsa.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Angela Palaiologou-Gallis, DDS

Phone

210-567-3567

PalaiologouA@uthscsa.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian Mealey, DDS, MS

Organizational Affiliation

University of Texas Health Science Center San Antonio

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Angela Palaiologou-Gallis, DDS

Organizational Affiliation

University of Texas Health Science Center San Antonio

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Health Science Center at San Antonio (Dental School)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian L Mealey, DDS, MS

Phone

210-567-3589

mealey@uthscsa.edu

First Name & Middle Initial & Last Name & Degree

Angela Paiologou-Gallis, DDS

Phone

210-567-3567

PalaiologouA@uthscsa.edu

First Name & Middle Initial & Last Name & Degree

Brian L Mealey, DDS, MS

First Name & Middle Initial & Last Name & Degree

Angela Palaiologou-Gallis Palaiologou-Gallis, DDS

12. IPD Sharing Statement

Learn more about this trial

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

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