Clinical trial NCT03943849: The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
Official title: The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Tooth Loss
Keywords: Bone graft
Tooth extraction
Dental pulp
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Bone fill as assessed by radiograph
timeFrame: immediately after placement of bone graft
measure: Bone fill as assessed by radiograph
timeFrame: 2 months after placement of bone graft
measure: Bone fill as assessed by radiograph
timeFrame: 4 months after placement of bone graft
Secondary outcomes:
measure: Extent of mineralization as assessed by von Kossa staining
timeFrame: 4 months after placement of bone graft
measure: Extent of mineralization as assessed by Xylenol Orange staining
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)
timeFrame: 4 months after placement of bone graft
measure: Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)
timeFrame: 4 months after placement of bone graft
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Karo Parsegian, DMD, MDSc, PhD
role: PRINCIPAL_INVESTIGATOR
References: