Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nanodiamonds and Antibiotics Modified Gutta-percha (NDGX) for Non-surgical Root Canal Therapy (RCT) Filler Material

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

Intervention / Treatment
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* Combination Product: ND and AMOX modified Gutta Percha
* Device: Gutta Percha


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gutta Percha<br>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<br>* 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).<br>* Other names: GP;|
| Experimental: ND and Amox modified Gutta Percha<br>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<br>* Gutta percha reinforced and modified with 5 nm diameter nanodiamonds and amoxicillin<br>* Other names: GPX;Device: Gutta Percha<br>* 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).<br>* Other names: GP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Root Canal Therapy