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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Dental Pulp Diseases; Dental Pulp Necrosis; Nerve Root Pain Nec

Treatments: Device: Nanodiamond reinforced Gutta Percha; Device: Gutta Percha

Study type: Interventional

Funder types: Other

Identifiers

NCT02698163

15-002015

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Gutta Percha

Active Comparator 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.

Treatment:

Device: Gutta Percha

Nanodiamond reinforced Gutta Percha

Experimental group

Description:

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.

Treatment:

Device: Gutta Percha

Device: Nanodiamond reinforced Gutta Percha