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Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy

NCT03376984 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2023-09-21

No results posted yet for this study

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).

Conditions

  • Dental Pulp Diseases
  • Dental Pulp Necrosis
  • Nerve Root Pain Nec

Interventions

COMBINATION_PRODUCT

ND and AMOX modified Gutta Percha

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

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).

Sponsors & Collaborators

Principal Investigators

  • Dean Ho, Ph.D. · University of California, Los Angeles

  • Mo K Kang, Ph.D,D.D.S. · University of California, Los Angeles

  • Eric C Sung, D.D.S. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376984 on ClinicalTrials.gov