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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02698163

Enrollment

Registered

2016-03-03

Start date

2016-03-31

Completion date

2021-03-31

Last updated

2022-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Root Canal Therapy

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.

Interventions

DEVICENanodiamond reinforced Gutta Percha

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

DEVICEGutta 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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Percent Reduction in Apical Radio-lucency	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.
Number of Participants With Absence of Apical Periodontitis	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

Measure	Time frame	Description
Number of Participants With Post-Operative Pain	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).
Number of Participants With Tooth Survival (6 Month)	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.
Number of Participants With Tooth Survival (1 Year)	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Gutta Percha 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. 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).	1
Nanodiamond Reinforced Gutta Percha 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. 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).	3
Total	4

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	0	1

Baseline characteristics

Characteristic	Nanodiamond Reinforced Gutta Percha	Total	Gutta Percha
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	1 Participants	2 Participants	1 Participants
Age, Categorical Between 18 and 65 years	2 Participants	2 Participants	0 Participants
Age, Continuous	67 years STANDARD_DEVIATION 21.66	68.25 years STANDARD_DEVIATION 17.86	72 years STANDARD_DEVIATION 0
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	3 participants	4 participants	1 participants
Sex: Female, Male Female	1 Participants	1 Participants	0 Participants
Sex: Female, Male Male	2 Participants	3 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 1	0 / 3
other Total, other adverse events	0 / 1	0 / 3
serious Total, serious adverse events	0 / 1	0 / 3

Outcome results

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.

Time frame: 1 year