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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT02698163
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arms: 2
• Actual Duration (Months): 60
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Pulp Diseases; Dental Pulp Necrosis; Nerve Root Pain Nec	Device: Nanodiamond reinforced Gutta Percha; Device: Gutta Percha	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Nanodiamond Modified Gutta Percha (NDGP) Composite for Non-surgical Root Canal Therapy (RCT) Filler Material Applied by Vertical Condensation Obturation Procedure
• Actual Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: 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).; Other Names: GP
Experimental: 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.	Device: Nanodiamond reinforced Gutta Percha; Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).; Other Names: NDGP ; Device: 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).; Other Names: GP

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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).

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095

Sponsors and Collaborators

• University of California, Los Angeles

Investigators

• Principal Investigator: Dean Ho, M.S., Ph.D., University of California, Los Angeles
• Principal Investigator: Mo K Kang, Ph.D.,D.D.S., University of California, Los Angeles
• Principal Investigator: Eric C Sung, University of California, Los Angeles

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 4, 2020

More Information

Publications

• 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.

• Responsible Party: Eric Sung, DDS, Professor of Clinical Dentistry, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02698163
• Other Study ID Numbers: 15-002015
• First Posted: Mar 3, 2016
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Eric Sung, DDS, Professor of Clinical Dentistry, University of California, Los Angeles: Root Canal Therapy
• Additional relevant MeSH terms: Dental Pulp Necrosis; Dental Pulp Diseases; Necrosis

Study Results

Participant Flow

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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. One tooth per participant was treated. 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).	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). One tooth per participant was treated.
Period Title: Overall Study
STARTED	1	3
COMPLETED	1	2
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha	Total
Arm/Group Description	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).	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).	Total of all reporting groups
Overall Participants	1	3	4
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	2 66.7%	2 50%
>=65 years	1 100%	1 33.3%	2 50%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72 (0)	67 (21.66)	68.25 (17.86)
Sex: Female, Male (Count of Participants)
Female	0 0%	1 33.3%	1 25%
Male	1 100%	2 66.7%	3 75%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%	3 100%	4 100%

Outcome Measures

1. Primary Outcome

Title	Percent Reduction in Apical Radio-lucency
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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).	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).
Measure Participants	1	2
Mean (Standard Deviation) [% Change in Diameter (mm)]	17.4 (0)	27.1 (4.6)

2. Primary Outcome

Title	Number of Participants With Absence of Apical Periodontitis
Description	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

Outcome Measure Data

Analysis Population Description

One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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).	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).
Measure Participants	1	2
Count of Participants [Participants]	1 100%	2 66.7%

3. Secondary Outcome

Title	Number of Participants With Post-Operative Pain
Description	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).
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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).	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).
Measure Participants	1	2
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Number of Participants With Tooth Survival (6 Month)
Description	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.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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).	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).
Measure Participants	1	2
Count of Participants [Participants]	1 100%	2 66.7%

5. Secondary Outcome

Title	Number of Participants With Tooth Survival (1 Year)
Description	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

Outcome Measure Data

Analysis Population Description

One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up.

Arm/Group Title	Gutta Percha	Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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).	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).
Measure Participants	1	2
Count of Participants [Participants]	1 100%	2 66.7%

Adverse Events

Time Frame	Adverse event data were collected at 3-month and 6-month follow-ups.
Arm/Group Title	Gutta Percha		Nanodiamond Reinforced Gutta Percha
Arm/Group Description	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).		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).
All Cause Mortality
	Gutta Percha		Nanodiamond Reinforced Gutta Percha
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)
Serious Adverse Events
	Gutta Percha		Nanodiamond Reinforced Gutta Percha
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	Gutta Percha		Nanodiamond Reinforced Gutta Percha
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.