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

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ClinicalTrials.gov Identifier: NCT03943849
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Karren Komitas, The University of Texas Health Science Center, Houston

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

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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 : August 1, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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




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 ]


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943849


Contacts
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Contact: Karren Komitas, DMD, MDSc, PhD 713-486-4087 karrenkomitas@uth.tmc.edu

Locations
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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
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Principal Investigator: Karren Komitas, DMD, MDSc, PhD The University of Texas Health Science Center, Houston

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Responsible Party: Karren Komitas, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03943849     History of Changes
Other Study ID Numbers: HSC-DB-18-0873
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karren Komitas, The University of Texas Health Science Center, Houston:
Bone graft
Tooth extraction
Dental pulp
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases
Dimenhydrinate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action