Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy

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.

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