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

NCT02698163 | Completed Results

• 1 other identifier: 15-002015
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Root Canal Therapy

Outcome Measures

Primary Outcomes (2)

• Percent Reduction in Apical Radio-lucency

  A radiograph of the treated tooth is made after 6 months post treatment, which will be compared with the radiograph of the treated tooth taken immediately after the RCT procedure. Clinical examination is performed at 6 months after the operation. The greatest diameters (mm) of the radio-lucency were recorded.

  6 months

• Number of Participants With Absence of Apical Periodontitis

  Apical periodontitis resulting in pain and apical lucency is measured. A radiograph of the treated tooth is made after 1 year post treatment, which will be compared with the radiographs of the treated tooth taken immediately after the RCT procedure and 6 months post treatment. Clinical examination is performed at 1 year after the operation.

  1 year

Secondary Outcomes (3)

• Number of Participants With Post-Operative Pain

  6 months

• Number of Participants With Tooth Survival (6 Month)

  6 months

• Number of Participants With Tooth Survival (1 Year)

  1 year

Study Arms (2)

Gutta Percha

ACTIVE COMPARATOR

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.

Device: Gutta Percha

Nanodiamond reinforced Gutta Percha

EXPERIMENTAL

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.

Device: Nanodiamond reinforced Gutta Percha; Device: Gutta Percha

Interventions

Nanodiamond reinforced Gutta Percha DEVICE

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

Also known as: NDGP

Nanodiamond reinforced 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; Nanodiamond reinforced Gutta Percha

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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 (1)

• 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

MeSH Terms

Conditions

Dental Pulp Diseases; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Eric Sung
• Organization: UCLA School of Dentistry

esung@dentistry.ucla.edu

(310) 206-6407

Study Officials

• Dean Ho, M.S., 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

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Dentistry

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: March 3, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: January 21, 2022
• Results First Posted: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)