Study Stopped
Lack of funding
The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2019
CompletedFirst Posted
Study publicly available on registry
May 9, 2019
CompletedStudy Start
First participant enrolled
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedFebruary 3, 2022
January 1, 2022
2.3 years
May 7, 2019
January 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Bone fill as assessed by radiograph
immediately after placement of bone graft
Bone fill as assessed by radiograph
2 months after placement of bone graft
Bone fill as assessed by radiograph
4 months after placement of bone graft
Secondary Outcomes (10)
Extent of mineralization as assessed by von Kossa staining
4 months after placement of bone graft
Extent of mineralization as assessed by Xylenol Orange staining
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
- +5 more secondary outcomes
Study Arms (2)
Particulate bone graft plus autogenous dental pulp tissue
EXPERIMENTALDental pulp will be isolated from teeth extracted for non-periodontal reasons chairside. The isolated dental pulp will be mixed with hydrated particulate bone graft, and the mixture will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.
Particulate bone graft
ACTIVE COMPARATORHydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.
Interventions
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
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.
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.
Resorbable or non-resorbable suture material
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karo Parsegian, DMD, MDSc, PhD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 7, 2019
First Posted
May 9, 2019
Study Start
May 1, 2023
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
February 3, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share