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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gutta Percha | Active Comparator | 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. |
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| Nanodiamond reinforced Gutta Percha | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanodiamond reinforced Gutta Percha | Device | Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Tooth Survival (6 Month) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26452304 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 4, 2020 |
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| Gutta Percha | Device | 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). |
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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 |
| 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 |
| FG001 | 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). One tooth per participant was treated. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up. | Posted | Mean | Standard Deviation | % Change in Diameter (mm) | 6 months |
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| 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. | One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up. | Posted | Count of Participants | Participants | 1 year |
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| 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). | One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up. | Posted | Count of Participants | Participants | 6 months |
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| 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. | One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up. | Posted | Count of Participants | Participants | 6 months |
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| 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. | One of the recruited patients in the Nanodiamond reinforced Gutta Percha group failed to follow up. | Posted | Count of Participants | Participants | 1 year |
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Adverse event data were collected at 3-month and 6-month follow-ups.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 1 | 0 | 1 | 0 | 1 |
| EG001 | 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). | 0 | 3 | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Sung | UCLA School of Dentistry | (310) 206-6407 | esung@dentistry.ucla.edu |
| Nov 11, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D003790 | Dental Pulp Necrosis |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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