Nanodiamond-Gutta Percha Composite Biomaterials for Root Canal Therapy

NCT ID: NCT03376984

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2025-06-30

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).

Detailed Description

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Gutta Percha

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).

Group Type: ACTIVE_COMPARATOR

Gutta Percha

Intervention Type: 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).

ND and Amox modified Gutta Percha

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.

Group Type: EXPERIMENTAL

ND and AMOX modified Gutta Percha

Intervention Type: COMBINATION_PRODUCT

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

Gutta Percha

Intervention Type: 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).

Interventions

ND and AMOX modified Gutta Percha

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

Intervention Type: COMBINATION_PRODUCT

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).

Intervention Type: DEVICE

Other Intervention Names

NDGX; NDGP; GPX; GP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dean Ho, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Mo K Kang, Ph.D,D.D.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Eric C Sung, D.D.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26452304 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29078364 (View on PubMed)

Other Identifiers

17-001308

Identifier Type: -

Identifier Source: org_study_id