Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material

NCT ID: NCT02698163

Last Updated: 2022-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2021-03-31

Brief Summary

Non-surgical root canal therapy (RCT) represents a standard of treatment that addresses infected pulp tissue in teeth and protects against future infection while preserving the tooth for the patient for mainly cosmetic purposes. RCT is offered as the better cosmetic, cheaper, and less time intensive treatment option for a patient compared to those of dental implantation. Dental implantation is the alternative to RCT, and they are both originally offered at the time of the initial consultation. RCT involves non-surgically removing dental pulp comprising blood vessels and nerve tissue, decontaminating residually infected tissue, and using a filler material to replace the non-surgically created space where the pulp was removed. Currently, standard of care treatment for RCT utilizes gutta-percha as the root canal filling material. Our research group has previously demonstrated NDGP's improvement in tensile strength compared to those of gutta-percha. This research studies a new type of filler, gutta-percha modified by the addition of nanodiamond material (NDGP). This is an equivalence study of NDGP and standard gutta-percha administration.

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

For all the patients in the control arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. The root canals will be filled with standard root canal filler material: gutta percha at the apical third up to and including the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.

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).

Nanodiamond reinforced Gutta Percha

For all the patients in the treatment arm of the study, standard treatment of care procedures will be given. Root canal therapy will be given according to the vertical obturation technique. 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, Nanodiamond gutta percha (NDGP) in the middle third, and again with gutta percha at the coronal third. The tooth will be restored with a crown for posterior teeth, or a composite filling for anterior teeth.

Group Type: EXPERIMENTAL

Nanodiamond reinforced Gutta Percha

Intervention Type: DEVICE

Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).

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

Nanodiamond reinforced Gutta Percha

Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

NDGP; GP

Eligibility Criteria

Inclusion Criteria

• 18 years old or older when patient is referred to UCLA endodontics department for root canal therapy
• Patient referral to UCLA endodontics department for root canal therapy

Exclusion Criteria

• preoperative periodontal disease
• prior non-surgical and surgical endodontic treatment
• currently taking medications used to treat osteoporosis or any form of IV biphosphonates
• allergic to dental materials
• dental phobia
• MD consult/medically compromised/prophylaxis needed
• developmental/congenital disorders
• craniofacial disorder/syndromic cases
• low pain tolerance ascertained from past dental experience
• current moderate to severe periodontitis
• previous RCT/initiated pulp therapy
• previous apical surgery
• previous surgical root canal procedure
• with psychiatric and/or mental health history
• poor oral hygiene
• poor diet
• illicit and/or recreational drug use
• complicated dental history

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

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Eric Sung, DDS

Professor of Clinical Dentistry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dean Ho, M.S., 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

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)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15-002015

Identifier Type: -

Identifier Source: org_study_id