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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material Applied by Vertical Condensation Obturation Procedure

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.

Detailed Summary:
Sponsor: University of California, Los Angeles

Current Primary Outcome:

  • 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.
  • 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: University of California, Los Angeles

Dates:
Date Received: February 25, 2016
Date Started: March 2016
Date Completion: September 2017
Last Updated: April 22, 2017
Last Verified: April 2017