Clinical trial NCT02698163: 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
Overall status: COMPLETED
Phase: NA
Conditions: Dental Pulp Diseases
Dental Pulp Necrosis
Nerve Root Pain Nec
Keywords: Root Canal Therapy
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-03-03
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent Reduction in Apical Radio-lucency
timeFrame: 6 months
measure: Number of Participants With Absence of Apical Periodontitis
timeFrame: 1 year
Secondary outcomes:
measure: Number of Participants With Post-Operative Pain
timeFrame: 6 months
measure: Number of Participants With Tooth Survival (6 Month)
timeFrame: 6 months
measure: Number of Participants With Tooth Survival (1 Year)
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Dean Ho, M.S., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Mo K Kang, Ph.D.,D.D.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Eric C Sung
role: PRINCIPAL_INVESTIGATOR
References:
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.