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Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

Primary Purpose

Alveolar Bone Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Porcine Xenograft (Zcore)

Bovine Xenograft (Bio-Oss)

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients will be included in this study if they qualify the following inclusion criteria:
Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol
A single rooted tooth that has been identified as requiring extraction
Desire a dental implant 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 only be included if they smoke <10 cigarettes per day

Exclusion Criteria:

Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
Patients will are mentally incompetent, prisoners, or pregnant.
Pregnant women or women intending to become pregnant during the study period.
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

UT Health Science Center School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test: Porcine Xenograft (Zcore)

Active Control: Bovine Xenograft (Bio-Oss)

Arm Description

Ridge preservation bone grafting surgery with porcine xenograft (Zcore)

Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)

Outcomes

Primary Outcome Measures

% Vital Bone Formation (Histological)

histologic determination of % vital bone formation

Secondary Outcome Measures

% Residual Graft Material (Histological)

histologic determination of % residual bone graft material

Full Information

NCT ID

NCT02802319

First Posted

June 13, 2016

Last Updated

January 4, 2019

Sponsor

The University of Texas Health Science Center at San Antonio

1. Study Identification

Unique Protocol Identification Number

NCT02802319

Brief Title

Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

Official Title

Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

July 2016 (undefined)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

Detailed Description

The study is designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials. This entire protocol involves procedures that are standard care. The study is a 2-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). In keeping with the protocol our study group has used several times before, the plan will be to extract non-molar teeth and graft with the test/control materials. Each subject will provide a single non-molar tooth site for study treatment. The graft material will be covered with a non-resorbable dense polytetrafluoroethylene (d-PTFE) membrane (TXT-200 singles, Osteogenics Inc). This d-PTFE membrane will be removed 4 weeks after placement during the 4-week post-op visit. Following 18-20 weeks of healing, the dental implant will be placed. To place a dental implant, an osteotomy (hole in the bone) is prepared into which the implant is placed. This osteotomy can be prepared with either a solid drill, in which case the bone that is removed is suctioned into the suction system, or with a hollow trephine drill into which a core of bone can be collected. The only "research procedure" being done in the current study is the collection of this bone core biopsy for histologic evaluation. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.

6. Conditions and Keywords

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

Alveolar Bone Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test: Porcine Xenograft (Zcore)

Arm Type

Experimental

Arm Description

Ridge preservation bone grafting surgery with porcine xenograft (Zcore)

Arm Title

Active Control: Bovine Xenograft (Bio-Oss)

Arm Type

Active Comparator

Arm Description

Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss)

Intervention Type

Device

Intervention Name(s)

Porcine Xenograft (Zcore)

Intervention Description

Ridge preservation bone grafting after tooth extraction

Intervention Type

Device

Intervention Name(s)

Bovine Xenograft (Bio-Oss)

Intervention Description

Ridge preservation bone grafting after tooth extraction

Primary Outcome Measure Information:

Title

% Vital Bone Formation (Histological)

Description

histologic determination of % vital bone formation

Time Frame

18-20 weeks after ridge preservation

Secondary Outcome Measure Information:

Title

% Residual Graft Material (Histological)

Description

histologic determination of % residual bone graft material

Time Frame

18-20 weeks after ridge preservation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients will be included in this study if they qualify the following inclusion criteria: Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol A single rooted tooth that has been identified as requiring extraction Desire a dental implant 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 only be included if they smoke <10 cigarettes per day Exclusion Criteria: Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule. Patients will are mentally incompetent, prisoners, or pregnant. Pregnant women or women intending to become pregnant during the study period. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Brian L Mealey, DDS, MS

Organizational Affiliation

UT Health Science Center at San Antonio, School of Dentistry

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT Health Science Center School of Dentistry

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31380563

Citation

Lai VJ, Michalek JE, Liu Q, Mealey BL. Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial. J Periodontol. 2020 Mar;91(3):361-368. doi: 10.1002/JPER.19-0211. Epub 2019 Aug 23.

Results Reference

derived

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Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials

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