Clinical trial NCT03376984: Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy
Official title: Nanodiamonds and Antibiotics Modified Gutta-percha (NDGX) for Non-surgical Root Canal Therapy (RCT) Filler Material
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Dental Pulp Diseases
Dental Pulp Necrosis
Nerve Root Pain Nec
Keywords: Root Canal Therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Root canal treatment success
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dean Ho, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Mo K Kang, Ph.D,D.D.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Eric C Sung, D.D.S.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.