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The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation

Primary Purpose

Tooth Loss

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Particulate bone graft
Autogenous dental pulp tissue
Resorbable collagen membrane
Suture
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Loss focused on measuring Bone graft, Tooth extraction, Dental pulp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Particulate bone graft plus autogenous dental pulp tissue

Particulate bone graft

Arm Description

Dental 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.

Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.

Outcomes

Primary Outcome Measures

Bone fill as assessed by radiograph
Bone fill as assessed by radiograph
Bone fill as assessed by radiograph

Secondary Outcome Measures

Extent of mineralization as assessed by von Kossa staining
Extent of mineralization as assessed by Xylenol Orange staining
Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)
Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody
Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)
Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody
Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)
Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody
Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)
Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)

Full Information

First Posted
May 7, 2019
Last Updated
January 19, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03943849
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Bone graft, Tooth extraction, Dental pulp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Particulate bone graft plus autogenous dental pulp tissue
Arm Type
Experimental
Arm Description
Dental 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.
Arm Title
Particulate bone graft
Arm Type
Active Comparator
Arm Description
Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.
Intervention Type
Other
Intervention Name(s)
Particulate bone graft
Other Intervention Name(s)
creos allo.gain, allogenic bone particulates
Intervention Description
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
Intervention Type
Other
Intervention Name(s)
Autogenous dental pulp tissue
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Resorbable collagen membrane
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Suture
Intervention Description
Resorbable or non-resorbable suture material
Primary Outcome Measure Information:
Title
Bone fill as assessed by radiograph
Time Frame
immediately after placement of bone graft
Title
Bone fill as assessed by radiograph
Time Frame
2 months after placement of bone graft
Title
Bone fill as assessed by radiograph
Time Frame
4 months after placement of bone graft
Secondary Outcome Measure Information:
Title
Extent of mineralization as assessed by von Kossa staining
Time Frame
4 months after placement of bone graft
Title
Extent of mineralization as assessed by Xylenol Orange staining
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR)
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR)
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR)
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR)
Time Frame
4 months after placement of bone graft
Title
Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR)
Time Frame
4 months after placement of bone graft

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karo Parsegian, DMD, MDSc, PhD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation

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