Ridge Preservation Following Tooth Extraction Using Two Mineralized Cancellous Bone Allografts
1 other identifier
interventional
44
1 country
1
Brief Summary
The study is a 2-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bone allograft that has been prepared by either freeze-drying or via a non-freeze-dried solvent process.This entire 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 a cancellous non-freeze-dried bone allograft (called PUROS graft). This test group will be compared to an active control group using cancellous freeze-dried bone allograft (called FDBA). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome). Each subject will provide a single non-molar tooth site for study treatment. After tooth extraction, the graft material will be placed and covered by a resorbable collagen membrane. Following 3 months of healing, the dental implant will be place, at which time a core of bone will be removed from the site as part of the preparation for the implant. 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 Sep 2015
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
July 31, 2015
CompletedFirst Posted
Study publicly available on registry
August 4, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
November 22, 2017
CompletedJanuary 23, 2018
November 1, 2017
2 years
July 31, 2015
September 27, 2017
December 18, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
% Vital Bone Formation (Histological)
histologic determination of % of vital bone formation
3 months after ridge preservation
Secondary Outcomes (1)
% Residual Graft Material (Histological)
3 months after ridge preservation
Study Arms (2)
PUROS (Non-Freeze-Dried bone allograft)
EXPERIMENTALRidge preservation bone grafting surgery with Non-Freeze-Dried cancellous bone allograft (PUROS)
FDBA (Freeze-Dried bone allograft)
ACTIVE COMPARATORRidge preservation bone grafting surgery with Freeze-Dried cancellous bone allograft (FDBA)
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
- Sensitivity or allergy to Bacitracin, Gentamicin, Polymyxin B Sulfate, alcohol and/or surfactants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Health Science Center at San Antonio, School of Dentistry
San Antonio, Texas, 78229, United States
Related Publications (1)
Corning PJ, Mealey BL. Ridge preservation following tooth extraction using mineralized freeze-dried bone allograft compared to mineralized solvent-dehydrated bone allograft: A randomized controlled clinical trial. J Periodontol. 2019 Feb;90(2):126-133. doi: 10.1002/JPER.18-0199. Epub 2018 Sep 19.
PMID: 30161278DERIVED
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
- No
- 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
July 31, 2015
First Posted
August 4, 2015
Study Start
September 1, 2015
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
January 23, 2018
Results First Posted
November 22, 2017
Record last verified: 2017-11