A NOVEL ENDODONTIC IRRIGANT

Abstract

ABSTRACT A Novel Endodontic irrigant This invention relates to the field of Dentistry and in particular to Endodontics. Sodium hypochlorite is the most commonly used root canal Irrigant because it is an excellent non-specific proteolytic and antimicrobial agent used during root canal treatment with concentrations ranging from 0.5% to 6% (higher concentrations are more toxic). NaOCl causes dentin collagen structure degeneration, affecting dentinal microhardness and reducing fracture resistance of endodontically treated teeth. Higher NaOCl concentration and longer application times were more effective in killing biofilm bacteria, and mature biofilms were more resistant to NaOCl than younger biofilms. Hyaluronic acid is a mucopolysaccharide and a natural biopolymer with a wide therapeutic benefits and versatile biomedical applications. Hyaluronic acid has antiadhesive and antibiofilm properties against bacterial biofilms.It is hygroscopic and has anti-inflammatory, anti-oedematous, analgesic, antioxidant, non-antigenicity, and bacteriostatic effects. This invention discloses a novel root canal irrigant wherein, Sodium hypochlorite was used as the main ingredient, hyaluronic acid as the vehicle, Propylene Glycol as a Preservative, flavouring agents in trace amounts and Milli Q water as solvent for hyaluronic acid powder.

Specification

Description:FORM 2

THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003

Complete Specification
(See section 10 and rule 13)



1.Title of the Invention:
A NOVEL ENDODONTIC IRRIGANT


2. Applicant Name

Name Nationality Address
Dr. K SATHYA NARAYANAN


Indian




Teeth care dental clinic, no 52/41, Venkataraman Street/KK road, (opposite to KVR flats), Ambattur, Chennai-600053
Sathyabama Dental college and Hospital, Chennai-600119


3. Preamble to the Description:

The following specification particularly describes the invention and how it is to be performed.


DESCRIPTION
FIELD OF INVENTION
The present invention generally relates to the field of Dentistry and
in particular to Endodontics.
BACKGROUND OF THE INVENTION
Success of endodontic treatment depends on complete debridement and minimizing the microbial count of infected root canal system followed by obturation of the root canals.
Bacteria and their by-products play an important role in the initiation and progression of pulpal and periapical diseases.
Bacteria present in endodontic infections include a restricted group of species due to varying oxygen pressures inside the root canal systems.
The predominant organisms are obligate anaerobes, mainly gram-negative bacilli and fusobacteria. Facultative anaerobes were also isolated from infected root canals.
Chemo-mechanical preparation is one of the most important phases of endodontic treatment. However, bacteria may survive inside the root canal even after careful chemo-mechanical preparation. These remaining bacteria grow and multiply inside the root canal if no root canal irrigant and antibacterial intracanal medicament is used between the endodontic appointments.
Thus, root canal irrigants may be a valuable adjunct to chemo mechanical preparation in the disinfection of the root canal systems, thus reducing the endodontic microbiota and thereby enhancing the periapical tissue repair.
OBJECT OF THE INVENTION
A prime object of the invention is to provide a novel Endodontic Irrigant in solution form which aids in thorough debridement of root canal system.
Another object of the invention is to provide an antibacterial composition that is used as an effective root canal irrigant.
Yet another object of the invention is to provide a new vehicle as an adjunct to sodium hypochlorite, which aids in disinfection of root canal system.
Another object of the invention is to improve the efficacy of sodium hypochlorite irrigant by using Hyaluronic acid as vehicle that increases the antimicrobial ability of the root canal irrigant.
Yet another object of the invention is to formulate an effective Root canal irrigant by combining sodium hypochlorite (1-3% concentration) with hyaluronic acid (0.1-1% concentration) which improves the antimicrobial efficacy, dentin properties and fracture resistance of endodontically treated teeth.
DETAILED DESCRIPTION OF THE INVENTION:
Sodium Hypochlorite:
Sodium hypochlorite (NaOCl) is the most commonly used root canal irrigant with concentration from 0.5% to 6%, with higher concentrations exhibiting a better tissue dissolving ability.
NaOCl is the preferred endodontic irrigant of choice because of its ability to dissolve necrotic and vital pulp tissues, organic components of dentin and biofilms in a rapid manner.
In water, NaOCl ionizes to produce Na+ and the hypochlorite ion,OCl- that establishes an equilibrium with hypochlorous acid,HOCl.
Between Ph 4 and 7, chlorine exists as hypochlorous acid HOCl, whereas Ph above 9 hypochlorite ion OCl- predominates.
It is the hypochlorous acid that is responsible for bacterial inactivation and the hypochlorite ion OCl- being less effective than the undissolved hypochlorous acid HOCl. (1)
Sodium hypochlorite is a strong base with a Ph 11 and its antimicrobial effectiveness is based on its high Ph (hydroxyl ion action), which is similar to the mechanism of action of Calcium hydroxide.
It effectively dissolved extracellular polymeric substance (EPS) matrix of endodontic biofilms, explaining its potent antibacterial activity. (2)


Limitations of Sodium Hypochlorite:
Higher concentrations of NaOCl are more toxic and if extruded through the root apex, it results in sodium hypochlorite accidents than lower concentrations.
If lower concentrations are to be used, it is recommended that the solutions be used in higher volume and in more frequent intervals to compensate for the limitations in effectiveness.
The chlorine ion, responsible for the tissue dissolution and antibacterial capacity is unstable and consumed rapidly within 2 minutes of tissue contact.
Despite 96% EPS dissolution by NaOCl, the remaining microbes exhibited higher proliferation with a resilient biofilm cell subpopulations which leads to biofilm recovery.
Mature biofilms are more resistant to NaOCl irrrigant than young biofilm and higher concentration of NaOCl is required to
Eliminate thick biofilms.
One study showed that the presence of dentin caused marked delay in killing of Enterococcus faecalis by 1% NaOCl. (3)
However, in vivo conditions the presence of organic matter like
inflammatory exudate, tissue remnants and microbial biomass consumes NaOCl and weakens its effect.
Therefore, continuous replenishing of irrigation solution and allowing sufficient contact time are important factors for the effectiveness of NaOCl. (4)
HYALURONIC ACID(HA):
Hyaluronic acid (HA) is a high molecular weight non-sulphated polysaccharide component of the glycosaminoglycan family, present in the extracellular matrices of many tissues such as skin, synovial joints and periodontal tissues. It is present in only low quantities in mineralized tissues such as cementum and alveolar bone. High levels of HA are present in gingival crevicular fluids.
The main characteristics of HA are viscoelasticity, hygroscopicity, hydrodynamics and volume maintenance. It helps in lubrication of tissues.
HA is one of the most hygroscopic molecules known in nature. When incorporated into an aqueous solution, this feature allows it to maintain conformational stiffness and retain water.
HA also presents important viscoelastic properties reducing the penetration of bacteria into the tissues, which plays a role in the wound healing process in both mineralized and non-mineralized tissues.
Hyaluronic acid is an ideal molecule to aid in wound healing, since it induces the early formation of granulation tissues, inhibits inflammation, and promotes wound healing in different tissues.
Furthermore, it has demonstrated bacteriostatic, fungistatic, anti-edematous and osteo-inductive effects.
The viscoelastic nature of HA and its biocompatibility and non-immunogenicity have led to its use in a large number of clinical applications, such as in controlled release and targeted drug delivery systems.
There are different forms of hyaluronic acid like hyaluronic acid methylcellulose hydrogel, hyaluronic acid microspheres,
Hyaluronic acid aminoethyl nanogel, thiolated hyaluronic acid microhydrogel which were used in drug delivery systems.
The four types of hyaluronic acid sodium hyaluronate, hydrolyzed hyaluronic acid, sodium hyaluronate crosspolymer, sodium acetylated hyaluronate may also be used as vehicle for this novel root canal irrigant.(5)
A recent study described a positive correlation between the HA scaffold and Stem cells of the apical papilla (SCAP) survival during regenerative endodontic procedures. (6)
This new formulation of sodium hypochlorite combined with hyaluronic acid was conducted which improved the antimicrobial properties of the root canal irrigant.
Further studies, are required to confirm the characterization of this new endodontic irrigant like pH, cytotoxicity, and antimicrobial properties of this novel endodontic irrigant.




A Novel vehicle for Sodium hypochlorite:
Various attempts have been made to improve the efficacy of Sodium hypochlorite by using surfactants that increases the flow and tissue contact of sodium hypochlorite with root canal dentin and to increase the antimicrobial ability of the irrigant.
To the best of our knowledge, Hyaluronic acid has not been mixed with Sodium hypochlorite and used as an endodontic irrigant. This Sodium hypochlorite combined with hyaluronic acid mixture is our new novel root canal irrigant.
Composition of Novel Endodontic irrigant solution:
Sodium Hypochlorite (1-3%) (Main ingredient) - 50-90 %
Hyaluronic acid (0.1-1%) (Vehicle) - 10-50%
Propylene Glycol (Preservative) - 0.1- 1%
Flavouring agents - Trace amounts
Milli Q Water- Solvent
Characterization and analysis of hyaluronic acid mixed with Sodium hypochlorite solution:
We prepared a novel root canal irrigant of 3% sodium hypochlorite combined with 1% hyaluronic acid in a 3:1 ratio and the mixed solution was subjected to UV spectrophotometer, FTIR test, and H1 NMR analysis to check for the presence of hyaluronic acid biopolymer and their results were as follows:
UV spectrophotometer Test:
We got an absorbance peak at around 200-210 nm which indicates the carboxyl group of hyaluronic acid
We got a shoulder peak at around 230-260 nm which indicates the presence of hydroxyl group of hyaluronic acid
The UV spectrum is used to identify the presence of specific functional groups in polysaccharides.
FTIR Analysis:
We got a broad peak at 3311 cm-1indicating the presence of hydroxyl group and a narrow peak at 1636 cm-1 indicating the presence of carboxyl groups
These peaks confirm the presence of hyaluronic acid characteristic functional groups such as hydroxyl, carboxyl groups.
H1 Nuclear Magnetic Resonance Spectroscopy test:
NMR proved a powerful technique for characterizing the linear and chemically cross-linked hyaluronic acid.
A signal around 1.6ppm were observed in the hyaluronic acid.
Two main peaks were identified in our sample solution.
A broad peak at 4-5 ppm indicates the presence of the -CH group of hyaluronic acid.
A signal around 1.6-2.5 ppm was observed in the hyaluronic acid mixed with sodium hypochlorite.
A signal around 2.2 ppm indicates the presence of N-acetyl group of hyaluronic acid.
Enterococcus faecalis is the predominant microorganism and occasionally the only species detected in root canals of teeth associated with persistent peri radicular lesions. It is a hardy microbe with certain virulence factors including lytic enzymes, cytolysin, aggregation substance, pheromones, and lipoteichoic acid. E. faecalis can invade dentinal tubules and remain viable within the tubules for prolonged period, adhere and form biofilm on dentin under different environmental conditions, resist intracanal disinfectants, and survive harsh conditions within root-filled teeth. Historically, efforts to eliminate E. faecalis and its concomitant biofilm have been limited using commonly used root canal irrigants. Furthermore, biofilm models that use this bacterium have been used to test the efficacy of different root canal disinfectants.
Disclosure
While the foregoing disclosure shows illustrative aspects of the disclosure, it should be noted that various changes and modifications could be made herein without departing from the scope of the disclosure as defined by the appended claims. Furthermore, although elements of the disclosure may be described or claimed in the singular, the plural is contemplated unless limitation to the singular is explicitly stated.
References:
1. llan Rotstein, John I Ingle. Ingles Endodontics. 7th edition, page no 641-642
2. He et al The dynamics of bacterial proliferation, viability, and extracellular polymeric substances in oral biofilm development. Journal of dentistry,143,2024,104882
3. Haapasalo HK et al Inactivation of local root canal medicaments by dentin: an in-vitro study. Int Endod J 22,126,2000
4. Kenneth M Hargreaves, Louis H Berman. Cohens Pathways of the pulp, first south asia edition, page no 251-253.
5. Huang G, Huang H. Application of hyaluronic acid as carriers in drug delivery. Drug Deliv. 2018 Nov;25(1):766-772. doi: 10.1080/10717544.2018.1450910. PMID: 29536778; PMCID: PMC6058522.
6. Vanessa Chrepa et al Evaluation of a Commercially available hyaluronic acid hydrogel (Restylane) as injectable scaffold for dental pulp regeneration: an in vitro evaluation. J Endod.2017 feb43(2):257-262.

 


, Claims:CLAIMS
We claim:

1. A root canal irrigant solution composition comprises Sodium hypochlorite (1-3%) as the main ingredient, hyaluronic acid (0.1-1%) as vehicle, Propylene Glycol as a Preservative, flavouring agents in trace amounts and Milli Q water as solvent for hyaluronic acid powder.

2. A root canal irrigant solution composition as claimed in claim 1, wherein, the solution includes between 50-90 percent by Volume/weight of Sodium hypochlorite, between 10-50 percent by Volume/weight of hyaluronic acid, 0.1- 1 percent by Volume/weight of Propylene Glycol as a Preservative, flavouring agents in trace amounts and Milli Q water as solvent for hyaluronic acid powder.



Dated this the 12th of November 2024

Senthil Kumar B
Agent for the applicant
IN/PA-1549

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