N/A
N=4
Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material
Dental Pulp Diseases · Dental Pulp Necrosis · Nerve Root Pain Nec
Bottom Line
View on ClinicalTrials.gov: NCT02698163 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcome: Primary: Percent Reduction in Apical Radio-lucency — 17.4; 27.1 % Change in Diameter (mm)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nanodiamond reinforced Gutta Percha (Device); Gutta Percha (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Reduction in Apical Radio-lucency |
17.4; 27.1 | — |
| PRIMARY Number of Participants With Absence of Apical Periodontitis |
1; 2 | — |
| SECONDARY Number of Participants With Post-Operative Pain |
0; 0 | — |
| SECONDARY Number of Participants With Tooth Survival (6 Month) |
1; 2 | — |
| SECONDARY Number of Participants With Tooth Survival (1 Year) |
1; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT02698163). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.