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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nanodiamond reinforced Gutta Percha
Gutta Percha
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pulp Diseases focused on measuring Root Canal Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, Los Angeles

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Gutta Percha

Nanodiamond reinforced Gutta Percha

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of Participants With Post-Operative Pain
Clinical examination is performed at 6 month after the operation to determine post-operative pain. Pain was assessed via a postoperative survey and a clinical examination (comparative pain scale 0 - 10; 0 is no pain and 10 is spontaneous pain).
Number of Participants With Tooth Survival (6 Month)
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.
Number of Participants With Tooth Survival (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.

Full Information

First Posted
February 25, 2016
Last Updated
January 12, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02698163
Brief Title
Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material
Official Title
Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material Applied by Vertical Condensation Obturation Procedure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pulp Diseases, Dental Pulp Necrosis, Nerve Root Pain Nec
Keywords
Root Canal Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gutta Percha
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Nanodiamond reinforced Gutta Percha
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Nanodiamond reinforced Gutta Percha
Other Intervention Name(s)
NDGP
Intervention Description
Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
Intervention Type
Device
Intervention Name(s)
Gutta Percha
Other Intervention Name(s)
GP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Percent Reduction in Apical Radio-lucency
Description
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.
Time Frame
6 months
Title
Number of Participants With Absence of Apical Periodontitis
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants With Post-Operative Pain
Description
Clinical examination is performed at 6 month after the operation to determine post-operative pain. Pain was assessed via a postoperative survey and a clinical examination (comparative pain scale 0 - 10; 0 is no pain and 10 is spontaneous pain).
Time Frame
6 months
Title
Number of Participants With Tooth Survival (6 Month)
Description
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.
Time Frame
6 months
Title
Number of Participants With Tooth Survival (1 Year)
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dean Ho, M.S., Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mo K Kang, Ph.D.,D.D.S.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric C Sung
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26452304
Citation
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.
Results Reference
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Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material

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