Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy

NCT03376984 | Withdrawn Phase 2 FDA Drug FDA Device

• 1 other identifier: 17-001308
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Root Canal Therapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Gutta Percha

ACTIVE COMPARATOR

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

ND and Amox modified Gutta Percha

EXPERIMENTAL

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; Device: Gutta Percha

Interventions

ND and AMOX modified Gutta Percha COMBINATION_PRODUCT

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

Also known as: NDGX, NDGP, GPX

ND and Amox modified Gutta Percha

Gutta Percha DEVICE

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).

Also known as: GP

Gutta Percha; ND and Amox modified Gutta Percha

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the patients must be over 18 years of age and in need of non-surgical RCT treatment during the consultation visit.

You may not qualify if:

• Molar teeth
• Osteoporosis medication or i.v. bisphosphonates
• Dental material allergies
• Allergic to penicillin and/or amoxicillin
• Have MD consult/medically compromised/prophylaxis needed

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• 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.

  PMID: 26452304 BACKGROUND

• 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.

  PMID: 29078364 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dean Ho, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Mo K Kang, Ph.D,D.D.S.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Eric C Sung, D.D.S.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 19, 2017
• Study Start: June 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)