N/A
N=21
Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
Alveolar Bone Loss
Bottom Line
View on ClinicalTrials.gov: NCT03149172 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Percent New Bone Formation — 41; 25; 26 percentage of new bone formation
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Equimatrix® (Device); Bio-Oss® (Device); Endobon® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent New Bone Formation |
41; 25; 26 | — |
| SECONDARY Bone Density |
25.6; 23.0; 12.9 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT03149172). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.