Formulation for the remineralization of teeth

Details Formulation for the remineralization of teeth Formulation for the remineralization of teeth

2002-03-13

2003-12-30

Pak, John (Department: 1616)

Drug, bio-affecting and body treating compositions

Dentifrices

Fluorine or fluorine compound containing

C424S053000, C424S055000, C424S057000, C424S641000, C424S643000, C514S574000, C514S738000, C514S835000, C514S900000, C514S901000, C514S902000

Reexamination Certificate

active

06669931

ABSTRACT:

This invention relates to the use of ozone in the treatment of dental caries and subsequent remineralization of teeth.
The great destructive disease of teeth is dental caries which may be defined as the acid dissolution of enamel, dentine or cementum as a consequence of the metabolism of micro-organisms living within deposits on the teeth known a plaque. Dental caries is believed to be associated with specific micro-organisms, the principal ones being
Streptococcus Mutans
, Lactobacilli,
Actinomyces Visosus Serovar
2,
Actinomyces Naeslundii
and “Intermediate” Actinomyces, other Streptococci and yeasts. These are acid producing micro-organisms which produce acids such as acetic and lactic acids from the dietary carbohydrates. The micro-organisms associated with dental caries are unique and are ecologically very different from those associated with, for example, infected root canals.
Dental caries is currently managed by one or more of the following:
(i) preventive treatment by, for example, dietary and oral hygiene measures and may include the topical application of chemotherapeutic agents;
(ii) the removal of dentine exhibiting the signs of active caries;
(iii) the protection of any newly exposed non-carious dentine with restorative material.
Measures aimed at the prevention or the arrest of dental caries are mainly based on the elimination of dental plaque from the surfaces of roots and the institution of dietary controls to reduce the frequency and quantity of readily fermentable carbohydrate ingestion. The mechanical removal of plaque has been a major platform for the prevention of dental caries for some time. However, this poses special problems in the case of primary root caries due to access problems. Because dentine has a Knoop hardness of 68 in contrast to enamel at 11, the mechanical removal of plaque from its surface inevitably results in some loss of tissue also. Toothbrush abrasion is now a very common phenomenon and invariably leads to the loss of root dentine from the facial aspects of teeth. Consequently, the traditional methods of plaque control in the prevention of dental caries create further problems even when access permits it to be used effectively.
Conventional caries removal and cavity preparation entail the use of high and low speed handpieces. However, disadvantages of this system include the perception that drilling is unpleasant for patients and local anesthetic is frequently required. Furthermore, handpieces are expensive to purchase and maintain and their use may lead to the removal of softened but uninfected dentine resulting in the excessive loss of tooth tissue.
Where restoration is required, all materials used to restore carious lesions have their limitations. For example, gold and ceramic are expensive and present a technical challenge for the practitioner. While amalgam is durable, predictable material, it has poor aesthetic qualities, is potentially toxic and may cause allergic reactions in some people.
It is an object of the invention to alleviate the disadvantages of the prior art.
It has now unexpectedly been found that ozone can penetrate carious tissue and can therefore be used in the treatment of dental caries.
According to the present invention there is provided the use of ozone in the preparation of a therapeutic system for the treatment of dental caries.
As used herein, the term “ozone” is intended to embrace pure ozone, oxonised air and ozonized aqueous media, such as water optionally containing a reductant, such as thiocyanate or peppermint.
The ozone is delivered at a pressure sufficient to penetrate the carious tissue and at a concentration and for a period of time sufficient to kill substantially all of the micro-organisms within the carious lesion.
Preferably, a needle-sized jet of pure ozone or ozonized air in a shroud of micro-organism-free aqueous medium, e.g. water optionally containing a reductant, is injected at the desired location.
If desired, a sealant of the type known in the art may be applied to a carious lesion following ozone treatment.
The advantages using ozone in the treatment of dental caries include the following:
1. It eliminates drilling and its attendant problems;
2. It is rapid and painless;
3. It does not require sophisticated methods of isolating the tooth;
4. No local anesthetic is required.
The invention is illustrated in the following Examples. Unless otherwise stated, the ozone delivered in the following Examples is present in air at a concentration of 5.2%,
EXAMPLE 1
Many studies concerning the clinical evaluation of ozone have been based on assessments of its harmful effects rather than demonstrating any therapeutic benefits it may offer. Ozone is one of nature's most powerful oxidants which accounts for its ability to kill bacteria, spores and viruses. Uniquely, ozone decomposes to a harmless, non-toxic and environmentally safe material (oxygen). In this investigation, a multicomponent evaluation of the oxidative consumption of salivary biomolecules by ozone (O
3
) has been performed using high resolution proton (
1
H) nuclear magnetic resonance (NMR) spectroscopy. The ozone-generating equipment employed in this study was designed by Purezone Ltd. (Ipswich, U.K.). Unstimulated human saliva samples were collected from 8 patients and each of them was divided into two equivalent portions (0.60 ml). The first of these was treated with O
3
generated from the above device for a period of 30 seconds; the second group of portions served as controls. Samples were subjected to
1
H NMR analysis at an operating frequency of 600 MHz. Results acquired revealed that O
3
treatment gave rise to (1) the oxidative decarboxylation of the salivary electron-donor pyruvate (generating acetate and CO
2
, as products), (2) oxidation of the volatile sulphur compound precursor methionine to its corresponding sulphoxide and (3) the oxidative consumption of salivary polyunsaturated fatty acids. Moreover, evidence for the O
3
-mediated oxidation of salivary 3-D-hydroxybutyrate was also obtained. High field
1
H NMR spectroscopy provides much useful analytical data regarding the fate of O
3
in human saliva, information which is of much relevance to its potential therapeutic actions in vivo.
EXAMPLE 2
Ozone Effect on Microflora from Primary Root Caries Ex-Vivo
Primary root carious lesions (PRCL) are a major clinical problem. The aim of this study was to establish if ozone could achieve effective microbial killing in PRCL. An ozone producing generator (Purezone Ltd., Ipswich, U.K.) was used in this ex-vivo study assessing the use of ozone on PRCL. In this study, soft PRCL requiring restoration were used as these are the most severe type of lesion found in humans. 20 freshly extracted teeth with PRCL requiring restoration were used. After plaque removal using a hand held standard fine nylon fiber sterile toothbrush with sterile water as a lubricant to cleanse the surface, each tooth was then isolated using sterile cotton wool rolls and dried using a dry sterile cotton wool roll. A sample of PRCL was taken using a sterile excavator from half of the most active part of the lesion. Subsequently, 10 seconds of the ozonized water was applied to the lesion and another sample was taken from the other half of the most active part of the lesion. Each sample was weighed and immediately placed in 1 ml of Fastidious Anaerobe Broth (FAB). To each 1 ml of FAB containing a biopsy o carious or ozone treated carious dentine, sterile glass beads were added. They were vortexed for 30 seconds to facilitate the extraction of any micro-organisms from the carious dentine and disperse any aggregates. After decimal dilution with FAB, 100 ml aliquots of these was spread on Fastidious Anaerobe Agar (LabM, Bury, Lancs., U.K.) supplemented with 5% (V/V) horse blood in an anaerobic chamber at 37° C. for four days. The mean±SE number of each colony type was counted and calculated.
Before Ozone
After 10 Seconds
Treatment
of Ozone Treatment
Mean ± SE of
5.9 ± 0.15
3.57 ± 0.37
Total cfu (Log
10
)
Using the paired Studen

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