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Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy (NDGX)

Primary Purpose

Dental Pulp Diseases, Dental Pulp Necrosis, Nerve Root Pain Nec

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ND and AMOX modified Gutta Percha
Gutta Percha
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Diseases focused on measuring Root Canal Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gutta Percha

ND and Amox modified Gutta Percha

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Root canal treatment success
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).

Secondary Outcome Measures

Full Information

First Posted
December 13, 2017
Last Updated
September 19, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT03376984
Brief Title
Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy
Acronym
NDGX
Official Title
Nanodiamonds and Antibiotics Modified Gutta-percha (NDGX) for Non-surgical Root Canal Therapy (RCT) Filler Material
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI left the institution
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Los Angeles

4. Oversight

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
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Diseases, Dental Pulp Necrosis, Nerve Root Pain Nec
Keywords
Root Canal Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gutta Percha
Arm Type
Active Comparator
Arm Description
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).
Arm Title
ND and Amox modified Gutta Percha
Arm Type
Experimental
Arm Description
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.
Intervention Type
Combination Product
Intervention Name(s)
ND and AMOX modified Gutta Percha
Other Intervention Name(s)
NDGX, NDGP, GPX
Intervention Description
Gutta percha reinforced and modified with 5 nm diameter nanodiamonds and amoxicillin
Intervention Type
Device
Intervention Name(s)
Gutta Percha
Other Intervention Name(s)
GP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Root canal treatment success
Description
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).
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Ho, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mo K Kang, Ph.D,D.D.S.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric C Sung, D.D.S.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26452304
Citation
Lee DK, Kim SV, Limansubroto AN, Yen A, Soundia A, Wang CY, Shi W, Hong C, Tetradis S, Kim Y, Park NH, Kang MK, Ho D. Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy. ACS Nano. 2015 Nov 24;9(11):11490-501. doi: 10.1021/acsnano.5b05718. Epub 2015 Oct 15.
Results Reference
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PubMed Identifier
29078364
Citation
Lee DK, Kee T, Liang Z, Hsiou D, Miya D, Wu B, Osawa E, Chow EK, Sung EC, Kang MK, Ho D. Clinical validation of a nanodiamond-embedded thermoplastic biomaterial. Proc Natl Acad Sci U S A. 2017 Nov 7;114(45):E9445-E9454. doi: 10.1073/pnas.1711924114. Epub 2017 Oct 23.
Results Reference
background

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Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy

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