Alveolar Bone Loss Clinical Trial
Official title:
Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
Verified date | September 2020 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 7, 2016 |
Est. primary completion date | June 7, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Tufts University School of Dental Medicine | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent New Bone Formation | Histomorphometric determination of % new bone formation | 4-6 months after ridge preservation surgery | |
Secondary | Bone Density | Measured by Micro CT Scanning | 4-6 months after ridge preservation surgery |
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