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

Dental Pulp Necrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698163
• Other study ID #: 15-002015
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2021

Study information

• Verified date: January 2022
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Nanodiamond reinforced Gutta Percha
Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
• Gutta Percha
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).

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months
Primary	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.	1 year
Secondary	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).	6 months
Secondary	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.	6 months
Secondary	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.	1 year