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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Device: Nanodiamond reinforced Gutta Percha
* Device: Gutta Percha


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gutta Percha<br>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<br>* 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).<br>* Other names: GP;|
| Experimental: Nanodiamond reinforced Gutta Percha<br>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<br>* Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).<br>* Other names: NDGP;Device: Gutta Percha<br>* 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).<br>* Other names: GP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Root Canal Therapy