Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 16, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedResults Posted
Study results publicly available
January 8, 2019
CompletedJanuary 8, 2019
December 1, 2018
2.2 years
June 13, 2016
December 13, 2018
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
% Vital Bone Formation (Histological)
histologic determination of % vital bone formation
18-20 weeks after ridge preservation
Secondary Outcomes (1)
% Residual Graft Material (Histological)
18-20 weeks after ridge preservation
Study Arms (2)
Test: Porcine Xenograft (Zcore)
EXPERIMENTALRidge preservation bone grafting surgery with porcine xenograft (Zcore)
Active Control: Bovine Xenograft (Bio-Oss)
ACTIVE COMPARATORRidge preservation bone grafting surgery with bovine xenograft (Bio-Oss)
Interventions
Ridge preservation bone grafting after tooth extraction
Ridge preservation bone grafting after tooth extraction
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- 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
- Positive medical history of endocarditis following oral or dental surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Health Science Center School of Dentistry
San Antonio, Texas, 78229, United States
Related Publications (1)
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.
PMID: 31380563DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Brian Mealey
- Organization
- UT Health Science Center at San Antonio
Study Officials
- PRINCIPAL INVESTIGATOR
Brian L Mealey, DDS, MS
UT Health Science Center at San Antonio, School of Dentistry
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Graduate Program Director, Periodontics
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 16, 2016
Study Start
July 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2018
Last Updated
January 8, 2019
Results First Posted
January 8, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share