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

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ClinicalTrials.gov Identifier: NCT02698163
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dean Ho, University of California, Los Angeles

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.

Condition or disease Intervention/treatment Phase
Dental Pulp Diseases Dental Pulp Necrosis Nerve Root Pain Nec Device: Nanodiamond reinforced Gutta Percha Device: Gutta Percha Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material Applied by Vertical Condensation Obturation Procedure
Actual Study Start Date : March 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Active Comparator: 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.
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).
Other Name: GP

Experimental: 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.
Device: Nanodiamond reinforced Gutta Percha
Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Other Name: NDGP

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).
Other Name: GP




Primary Outcome Measures :
  1. Absence of apical periodontitis [ Time Frame: 6 months ]
    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.

  2. Absence of apical periodontitis [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Assessing change in post-operative pain [ Time Frame: 6 months and 1 year ]
    Clinical examination is performed at 6 months and 1 year after the operation to assess change in post-operative pain.

  2. Tooth survival [ Time Frame: 6 months ]
    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.

  3. Tooth survival [ Time Frame: 1 year ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698163


Contacts
Contact: Mo K Kang, Ph.D.,D.D.S. (310) 825-8048 mkang@dentistry.ucla.edu
Contact: Eric C Sung, D.D.S. (310) 206-6259 esung@dentistry.ucla.edu

Locations
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Mo K Kang, Ph.D.,D.D.S.    310-825-8048    mkang@dentistry.ucla.edu   
Contact: Eric C Sung, D.D.S.    (310) 206-6259    esung@dentistry.ucla.edu   
Principal Investigator: Dean Ho, M.S., Ph.D.         
Sub-Investigator: Theodore W Kee, B.S.         
Sub-Investigator: Dong-Keun Lee, Ph.D.         
Principal Investigator: Eric C Sung, D.D.S.         
Principal Investigator: Mo K Kang, Ph.D.,D.D.S.         
Sub-Investigator: Zhangrui Liang, D.D.S.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: 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

Publications:
Responsible Party: Dean Ho, Professor in the Division of Oral Biology and Medicine, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02698163     History of Changes
Other Study ID Numbers: 15-002015
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dean Ho, University of California, Los Angeles:
Root Canal Therapy

Additional relevant MeSH terms:
Necrosis
Dental Pulp Necrosis
Dental Pulp Diseases
Pathologic Processes
Tooth Diseases
Stomatognathic Diseases