Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy (NDGX)
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| ClinicalTrials.gov Identifier: NCT03376984 |
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Recruitment Status :
Recruiting
First Posted : December 19, 2017
Last Update Posted : November 4, 2020
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Sponsor:
University of California, Los Angeles
Information provided by (Responsible Party):
Dean Ho, University of California, Los Angeles
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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 |
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 : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 54 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Nanodiamonds and Antibiotics Modified Gutta-percha (NDGX) for Non-surgical Root Canal Therapy (RCT) Filler Material |
| Estimated Study Start Date : | January 2021 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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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).
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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 |
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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.
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Combination Product: ND and AMOX modified Gutta Percha
Gutta percha reinforced and modified with 5 nm diameter nanodiamonds and amoxicillin
Other Names:
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 :
- 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).
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
| Contact: Mo K Kang, Ph.D,D.D.S. | (310) 825-8048 | mkang@dentistry.ucla.edu | |
| Contact: Eric C Sung, D.D.S. | (310) 206-6259 | esung@dentistry.ucla.edu |
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 |
| Other Study ID Numbers: |
17-001308 |
| First Posted: | December 19, 2017 Key Record Dates |
| Last Update Posted: | November 4, 2020 |
| Last Verified: | November 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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 |
Keywords provided by Dean Ho, University of California, Los Angeles:
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Root Canal Therapy |
Additional relevant MeSH terms:
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Dental Pulp Necrosis Dental Pulp Diseases Necrosis |
Pathologic Processes Tooth Diseases Stomatognathic Diseases |