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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03943849

Recruitment Status Not yet recruiting

First Posted May 9, 2019

Last update posted May 9, 2019

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:Tooth Loss
  • Intervention/Treatment: Other: Autogenous dental pulp tissue
    Other: Particulate bone graft
    Other: Resorbable collagen membrane
    Other: Suture
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: July 2021
Arms and interventions
Arm Intervention/treatment
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: 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
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: 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
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
  • 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

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

Locations

United States, Texas
The University of Texas Health Science Center at Houston
Houston

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

More Information
  • Responsible Party: 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by The University of Texas Health Science Center, Houston: Bone graft
    Tooth extraction
    Dental pulp
  • Additional relevant MeSH terms: Tooth Loss