Tooth Loss
Conditions
Keywords
Bone graft, Tooth extraction, Dental pulp
Brief summary
The purpose of this study is to examine and compare the effects of autogenous dental pulp tissue on bone formation in the extraction sockets as compared to commonly used particulate bone graft. The effects on bone formation will be examined using a wide variety of assays.
Interventions
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
OTHERAutogenous dental pulp tissue
Dental pulp will be isolated from teeth extracted for non-periodontal reasons chairside, mixed with hydrated particulate bone graft, and then placed in the extraction socket.
OTHERResorbable collagen membrane
After placement of particulate bone graft or particulate bone graft plus autogenous dental pulp tissue, socket will be covered by a resorbable collagen membrane and sutured.
OTHERSuture
Resorbable or non-resorbable suture material
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* American Society of Anesthesiologists (ASA) Physical Status Classification System ASA 1 (A normal healthy patient) or ASA 2 (A patient with mild systemic disease) * never smoker * patients with planned tooth extraction * intact extraction sockets * no medication or antibiotics intake for at least 6 months prior to the procedure * patients who gave their consent to participate in the study.
Exclusion criteria
* vulnerable subjects (children, pregnant and lactating women, patients with learning disabilities, and prisoners) * inability to obtain pulp tissue (for example, due to previous endodontic therapy, obliterated pulp canals)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone fill as assessed by radiograph | immediately after placement of bone graft |
Secondary
| Measure | Time frame |
|---|---|
| Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody | 4 months after placement of bone graft |
| Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR) | 4 months after placement of bone graft |
| Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody | 4 months after placement of bone graft |
| Extent of mineralization as assessed by von Kossa staining | 4 months after placement of bone graft |
| Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR) | 4 months after placement of bone graft |
| Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR) | 4 months after placement of bone graft |
| Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody | 4 months after placement of bone graft |
| Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR) | 4 months after placement of bone graft |
| Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR) | 4 months after placement of bone graft |
| Extent of mineralization as assessed by Xylenol Orange staining | 4 months after placement of bone graft |
Countries
United States
Outcome results
None listed