Clinical trial

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

Name

17-001308

Description

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).

Trial arms

Trial start

2023-06-01

Estimated PCD

2024-12-01

Trial end

2025-06-01

Status

Withdrawn

Phase

Early phase I

Treatment

ND and AMOX modified Gutta Percha

Gutta percha reinforced and modified with 5 nm diameter nanodiamonds and amoxicillin

Arms:

ND and Amox modified Gutta Percha

Other names:

NDGX, NDGP, GPX

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).

Arms:

Gutta Percha, ND and Amox modified Gutta Percha

Other names:

Primary endpoint

Root canal treatment success

2 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

Updated at

2023-09-21

1 organization

1 product

3 indications

Organization

University of California, Los Angeles

Product

Indication

Indication

Indication