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出境医 / 临床实验 / The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation

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

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.

Condition or disease Intervention/treatment Phase
Tooth Loss Other: Particulate bone graft Other: Autogenous dental pulp tissue Other: Resorbable collagen membrane Other: Suture Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Particulate bone graft plus autogenous dental pulp tissue
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.
 Other: Particulate bone graft
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
Other Names:
  • creos allo.gain
  • allogenic bone particulates

Other: Autogenous 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.

Other: Resorbable 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.

Other: Suture
Resorbable or non-resorbable suture material
Active Comparator: Particulate bone graft
Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.
 Other: Particulate bone graft
Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
Other Names:
  • creos allo.gain
  • allogenic bone particulates

Other: Resorbable 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.

Other: Suture
Resorbable or non-resorbable suture material
Outcome Measures
Primary Outcome Measures :
  1. Bone fill as assessed by radiograph [ Time Frame: immediately after placement of bone graft ]
  2. Bone fill as assessed by radiograph [ Time Frame: 2 months after placement of bone graft ]
  3. Bone fill as assessed by radiograph [ Time Frame: 4 months after placement of bone graft ]

Secondary Outcome Measures :
  1. Extent of mineralization as assessed by von Kossa staining [ Time Frame: 4 months after placement of bone graft ]
  2. Extent of mineralization as assessed by Xylenol Orange staining [ Time Frame: 4 months after placement of bone graft ]
  3. Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  4. Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody [ Time Frame: 4 months after placement of bone graft ]
  5. Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  6. Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody [ Time Frame: 4 months after placement of bone graft ]
  7. Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  8. Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody [ Time Frame: 4 months after placement of bone graft ]
  9. Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  10. Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations

Contacts
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Contact: Karo Parsegian, DMD, MDSc, PhD 713-486-4087 Karo.Parsegian@uth.tmc.edu

Locations
Layout table for location information
United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Layout table for investigator information
Principal Investigator: Karo Parsegian, DMD, MDSc, PhD The University of Texas Health Science Center, Houston
Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 9, 2019
Last Update Posted Date November 9, 2020
Estimated Study Start Date  ICMJE May 1, 2021
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Bone fill as assessed by radiograph [ Time Frame: immediately after placement of bone graft ]
  • Bone fill as assessed by radiograph [ Time Frame: 2 months after placement of bone graft ]
  • Bone fill as assessed by radiograph [ Time Frame: 4 months after placement of bone graft ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2019)
  • Extent of mineralization as assessed by von Kossa staining [ Time Frame: 4 months after placement of bone graft ]
  • Extent of mineralization as assessed by Xylenol Orange staining [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker Bsp assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker BSP assessed by immunostaining using anti-BSP antibody [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker Bglap assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker BGLAP assessed by immunostaining using anti-BGLAP antibody [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker Dmp1 assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker DMP1 assessed by immunostaining using anti-DMP1 antibody [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker Col1a1 assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
  • Expression of osteoblastic marker Sost assessed by quantitative PCR (qPCR) [ Time Frame: 4 months after placement of bone graft ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
Official Title  ICMJE The Use of Dental Pulp Tissue as an Autogenous Graft for Ridge Augmentation
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tooth Loss
Intervention  ICMJE
  • Other: Particulate bone graft
    Creos allo.gain allogenic bone particulate mineralized cortical bone will be hydrated and placed in the extraction socket.
    Other Names:
    • creos allo.gain
    • allogenic bone particulates
  • Other: Autogenous 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.
  • Other: Resorbable 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.
  • Other: Suture
    Resorbable or non-resorbable suture material
Study Arms  ICMJE
  • Experimental: Particulate bone graft plus autogenous dental pulp tissue
    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.
    Interventions:
    • Other: Particulate bone graft
    • Other: Autogenous dental pulp tissue
    • Other: Resorbable collagen membrane
    • Other: Suture
  • Active Comparator: Particulate bone graft
    Hydrated particulate bone graft will be placed in the debrided extraction socket. The socket will be covered by a resorbable collagen membrane and sutured.
    Interventions:
    • Other: Particulate bone graft
    • Other: Resorbable collagen membrane
    • Other: Suture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 7, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2022
Estimated Primary Completion Date September 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Karo Parsegian, DMD, MDSc, PhD 713-486-4087 Karo.Parsegian@uth.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03943849
Other Study ID Numbers  ICMJE HSC-DB-18-0873
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Karo Parsegian, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karo Parsegian, DMD, MDSc, PhD The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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