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Completed

NCT Number: NCT02698163

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

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.

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Key information

Conditions

Dental Pulp Diseases Dental Pulp Necrosis Necrosis Nerve Root Pain Nec Pathologic Processes Pathological Conditions, Signs and Symptoms Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nanodiamond reinforced Gutta Percha

Device

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

Other names: NDGP

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).

Other names: GP

Primary outcomes

  1. Percent Reduction in Apical Radio-lucency

    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. The greatest diameters (mm) of the radio-lucency were recorded.

  2. Number of Participants With Absence of Apical Periodontitis

    Time frame: 1 year

    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 outcomes

  1. Number of Participants With Post-Operative Pain

    Time frame: 6 months

    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).

  2. Number of Participants With Tooth Survival (6 Month)

    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. Number of Participants With Tooth Survival (1 Year)

    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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2016
Registry last updated
Jan 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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