Back to resultsComparison of Post Tooth Extraction Healing Using Different Xenograft Materials
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Equimatrix®
Bio-Oss®
Endobon®
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- Non-restorable single rooted tooth in anterior or premolar region
- Patient previously treatment planned for implant procedure and implant restoration.
- > 10 mm from maxillary sinus or inferior alveolar canal (IAC)
- Intact buccal bone (only minor dehiscence or fenestrations (approximately < 50% of socket depth) can be accepted
- Non-smokers.
- Patients treatment planned for extraction and ridge preservation at Tufts University School of Dental Medicine.
Exclusion Criteria:
- Poor oral hygiene (plaque index>30%).
Systemic diseases that affect bone metabolism:
i. Osteoporosis ii. Osteomalacia iii. Hyperthyroidism iv. Hyperparathyroidism v. Paget's disease
Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):
i. Severe chronic periodontitis ii. Aggressive periodontitis iii. Necrotizing ulcerative periodontitis iv. Crohn's disease v. Multiple sclerosis vi. Rheumatoid arthritis vii. Systemic lupus erythematosus
- History of radiation to the head and neck, and /or chemotherapy.
- Current corticosteroid therapy.
- History of IV Bisphosphonates therapy or >3 years of oral intake.
- Infectious diseases such as HIV, tuberculosis, Hepatitis (self-report).
- Known allergy to research related materials.
- Self-reported pregnancy or lactation
Sites / Locations
- Tufts University School of Dental Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Equimatrix®
Bio-Oss®
Endobon®
Arm Description
Equimatrix® + Mucograft or alternatives
Bio-Oss® + Mucograft or alternatives
Endobon® + Mucograft or alternatives
Outcomes
Primary Outcome Measures
Percent New Bone Formation
Histomorphometric determination of % new bone formation
Secondary Outcome Measures
Bone Density
Measured by Micro CT Scanning
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03149172
Brief Title
Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
Official Title
Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 20, 2014 (Actual)
Primary Completion Date
June 7, 2016 (Actual)
Study Completion Date
December 7, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets.
Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.
Detailed Description
This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®.
Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
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
Outcomes Assessor
Masking Description
The surgeon and the subject will not be blinded. The evaluation of the core histology will be done by a blinded investigator.
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Equimatrix®
Arm Type
Experimental
Arm Description
Equimatrix® + Mucograft or alternatives
Arm Title
Bio-Oss®
Arm Type
Experimental
Arm Description
Bio-Oss® + Mucograft or alternatives
Arm Title
Endobon®
Arm Type
Experimental
Arm Description
Endobon® + Mucograft or alternatives
Intervention Type
Device
Intervention Name(s)
Equimatrix®
Intervention Description
Ridge preservation bone grafting after tooth extraction
Intervention Type
Device
Intervention Name(s)
Bio-Oss®
Intervention Description
Ridge preservation bone grafting after tooth extraction
Intervention Type
Device
Intervention Name(s)
Endobon®
Intervention Description
Ridge preservation bone grafting after tooth extraction
Primary Outcome Measure Information:
Title
Percent New Bone Formation
Description
Histomorphometric determination of % new bone formation
Time Frame
4-6 months after ridge preservation surgery
Secondary Outcome Measure Information:
Title
Bone Density
Description
Measured by Micro CT Scanning
Time Frame
4-6 months after ridge preservation surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non-restorable single rooted tooth in anterior or premolar region
Patient previously treatment planned for implant procedure and implant restoration.
> 10 mm from maxillary sinus or inferior alveolar canal (IAC)
Intact buccal bone (only minor dehiscence or fenestrations (approximately < 50% of socket depth) can be accepted
Non-smokers.
Patients treatment planned for extraction and ridge preservation at Tufts University School of Dental Medicine.
Exclusion Criteria:
Poor oral hygiene (plaque index>30%).
Systemic diseases that affect bone metabolism:
i. Osteoporosis ii. Osteomalacia iii. Hyperthyroidism iv. Hyperparathyroidism v. Paget's disease
Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):
i. Severe chronic periodontitis ii. Aggressive periodontitis iii. Necrotizing ulcerative periodontitis iv. Crohn's disease v. Multiple sclerosis vi. Rheumatoid arthritis vii. Systemic lupus erythematosus
History of radiation to the head and neck, and /or chemotherapy.
Current corticosteroid therapy.
History of IV Bisphosphonates therapy or >3 years of oral intake.
Infectious diseases such as HIV, tuberculosis, Hepatitis (self-report).
Known allergy to research related materials.
Self-reported pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Hur, DDS, DMD, MS
Organizational Affiliation
Tufts University School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
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