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ClinicalTrials.gov Identifier: NCT03376984
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted Black Geometric Bag Folding Meoaeo Apricot Diamond Td0qdE: February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Dean Ho, University of California, Los Angeles

Brief Summary:
The purpose of this study is to to compare root canal therapy success between two root canal filler materials: 1) gutta percha (GP), 2) gutta percha modified with nanodiamonds and amoxicillin (NDGX). Gutta percha is the current standard root canal filler material used during non-surgical root canal therapy (RCT). Gutta percha modified with nanodiamonds and amoxicillin is an investigational root canal filler material, not yet FDA approved for use as described in this study. The safety and usefulness of NDGX is being tested in this study in comparison to the current standard of care, gutta percha (GP).

Condition or disease Intervention/treatment Phase
Dental Pulp Diseases Dental Pulp Necrosis Nerve Root Pain Nec Combination Product: ND and AMOX modified Gutta Percha Device: Gutta Percha Phase 2 Phase 3

Detailed Description:
This minimal-risk comparison (non-inferiority) study aims to investigate the advantages of Nanodiamond and Amoxicillin modified gutta percha (NDGX) as a root canal filler material for non-surgical root canal therapy. In comparison with the current standard of care, gutta percha (GP), NDGX benefits the patient because NDGX is stronger, may better prevent bacterial reinfection, and potentially reduces complications of non-surgical root canal therapy (RCT) such as tooth fracture, thereby improving overall treatment prognosis. In this study, patients with non-molar teeth needing root canals will be recruited and randomized into two RCT filler material patient groups, with 27 patients with roots filled with the control (GP), and 27 patients with roots filled with NDGX. All patients will be receiving standard of care, and their involvement in our study will only deviate from standard of care in the informed consent process, initial randomization of the root canal filler material, and clinical data collection for research record (already collected in standard of care) from their visits. All patients in the control arm of the study will undergo root canal therapy in which the root canals will be filled with GP. All patients in the NDGX arm of the study will undergo root canal therapy with canals filled with GP in the apical (lower third) end and NDGX in the middle and top thirds of the root canal. In accordance with the standard of care, patients will ideally commit to a total of five visits over a two year period in line with the current standard of care: one pre-treatment consultation appointment, a root canal therapy appointment, a 6 month follow-up appointment, a 1 year follow-up appointment, and a 2 year follow-up appointment. Following standard of care protocol, additional follow-up appointments prior to the 6 month, 1 year, and 2 year follow-up appointments may be required in the event of infection, persistent pain of the root canal following the treatment, and/or at clinician's discretion. Comparison between the control (GP) and NDGX arms of the study will be based upon patient data collected, which will be used to determine clinical "success" derived from reduction and/or absence of a periapical radiolucency and verified with objective and subjective clinical findings such as patient symptoms. Patient data will be categorized by age, weight, gender, and use of other drugs, which may alter the pain assessment and pilot study success indicators.

Study Type : Bag Bag Matte Chiffon Chain Jelly Shoulder Bag Mini Bag Bag Blue Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bag Bag Bag Mini Blue Bag Jelly Chiffon Chain Shoulder Bag Matte Nanodiamonds and Antibiotics Modified Gutta-percha (NDGX) for Non-surgical Root Canal Therapy (RCT) Filler Material
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: Gutta Percha
Subjects in both arms of the study will be receiving standard of care RCT and routine follow-up examinations/assessments at 6 months, 1 year, and 2 years post RCT. For all the patients into the control arm of the study, the root canals will be filled with gutta percha (current standard of care), using the vertical condensation obturation technique (standard of care RCT technique).
Device: Gutta Percha
Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
Other Name: GP

Experimental: ND and Amox modified Gutta Percha
Subjects in both arms of the study will be receiving standard of care RCT and routine follow-up examinations/assessments at 6 months, 1 year, and 2 years post RCT. The difference between the two arms will be the root canal filler material used. The root canals for the treatment arm of the study will be filled with gutta percha at the apical third, gutta percha modified with nanodiamonds and amoxicillin (NDGX) will be used for the middle and coronal thirds.
Combination Product: ND and AMOX modified Gutta Percha
Gutta percha reinforced and modified with 5 nm diameter nanodiamonds and amoxicillin
Other Names:
  • NDGX
  • NDGP
  • GPX

Device: Gutta Percha
Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
Other Name: GP




Primary Outcome Measures :
  1. Root canal treatment success [ Time Frame: 2 years ]
    Defined as the reduction and/or absence of in periapical radiolucency (PARL) that is verified with objective and subjective clinical findings such as patient symptoms reported (e.g. reported pain levels).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Bag Shoulder Matte Mini Jelly Bag Bag Bag Bag Chain Blue Chiffon Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All of the patients must be over 18 years of age and in need of non-surgical RCT treatment during the consultation visit.

Exclusion Criteria:

  • Molar teeth
  • Osteoporosis medication or i.v. bisphosphonates
  • Dental material allergies
  • Allergic to penicillin and/or amoxicillin
  • Have MD consult/medically compromised/prophylaxis needed

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): NCT03376984


Contacts

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Mo K Kang, Ph.D.,D.D.S.    310-825-8048    mailto:mkang@dentistry.ucla.edu   
Contact: Eric C Sung, D.D.S.    (310) 206-6259    mailto:esung@dentistry.ucla.edu   
Principal Investigator: Dean Ho, Ph.D.         
Sub-Investigator: Theodore W Kee, M.S.         
Sub-Investigator: Dong-Keun Lee, Ph.D.         
Principal Investigator: Mo K Kang, Ph.D,D.D.S.         
Principal Investigator: Eric C Sung, D.D.S.         
Sub-Investigator: Daniel Choi, D.D.S.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Dean Ho, Ph.D. University of California, Los Angeles
Principal Investigator: Mo K Kang, Ph.D,D.D.S. University of California, Los Angeles
Principal Investigator: Eric C Sung, D.D.S. University of California, Los Angeles

Publications:
Responsible Party: Dean Ho, Professor in the Division of Oral Biology and Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03376984     History of Changes
Other Study ID Numbers: 17-001308
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: February 21, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Dean Ho, University of California, Los Angeles:
Root Canal Therapy
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Model Bag Bullet Black Shoulder Miami Red ZwZqxBY Additional relevant MeSH terms:
Necrosis
Dental Pulp Necrosis
Dental Pulp Diseases
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Pathologic Processes
Tooth Diseases
Stomatognathic Diseases