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Title:
INTEGRATED DIAGNOSTIC SYSTEM FOR THE ORAL CAVITY
Document Type and Number:
WIPO Patent Application WO/2001/097685
Kind Code:
A1
Abstract:
An integrated diagnostic system for the oral cavity, which allows various levels of dental analyses, comprising a software program for a diagnostic classification of the patient, a series of diagnostic products necessary for the tests and relative technological and patient-assistance data.

Inventors:
CORTELLINI PIERPAOLO (IT)
TONETTI MAURIZIO (GB)
Application Number:
PCT/EP2001/006632
Publication Date:
December 27, 2001
Filing Date:
June 19, 2001
Export Citation:
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Assignee:
TANGRAM ODIS S R L (IT)
CORTELLINI PIERPAOLO (IT)
TONETTI MAURIZIO (GB)
International Classes:
A61B5/00; G06F19/00; (IPC1-7): A61B5/00
Domestic Patent References:
WO1997011635A11997-04-03
WO1998002836A21998-01-22
Foreign References:
US5619991A1997-04-15
Attorney, Agent or Firm:
Coppo, Alessandro (10 Milan, IT)
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Claims:
CLAIMS
1. An integrated diagnostic system for the oral cavity, which allows various levels of dental analyses, charac terized in that it comprises a diagnostic classification software program and the diagnostic products necessary for the tests, in order to obtain at least one of the following types of medical reports for a patient: identification of the main pathologies of the oral cavity; evaluation of tooth decay and of the risk of being affected by tooth decay; diagnosis of halitosis and observation of its ori gin; evaluation of the periodontal situation and of the risk of becoming affected by periodontitis ; clinical and instrumental implant risk evaluation.
2. The integrated diagnostic system according to claim 1, characterized in that said software program corre lates, by means of algorithms, a series of clinical and microbiological parameters, evaluates the risks for said patient of being affected by tooth decay, correlates the case history of the patient, the data deriving from an objective examination and periodontal examination, the data deriving from laboratory tests, and it provides a diagnostic opinion, evaluating the gravity and diffusion of periodontal diseases and the risks for said patient of the insertion of osseointegrated implants.
3. The integrated diagnostic system according to claim 2, characterized in that said software program correlates the case history and dietetic data of said patient with a series of instrumental and objective tests, in order to identify the presence, gravity, pathogenesis and origin of said halitosis.
4. An implementing method for the integrated diagnostic system according to claim 1, characterized in that it comprises at least the following phases: interrogation of said software in order to formulate questions contained in various questionnaires for ob taining the different types of medical reports re quired; subsequent network interrogation of a remote service center, which provides said medical reports; continuous updating of said software.
5. The integrated diagnostic system according to claim 2, characterized in that said software program comprises a series of variables, correlated with each other, which can be controlled.
6. The integrated diagnostic system according to claim 5, characterized in that said variables comprise personal data, a screening variable, number of decayed teeth and the possible risk of tooth decay with case history, food report and laboratory tests, halitosis with case history, organoleptic test, halitometry and the periodontal situa tion with periodontal case history, the insertion of periodontal data, periodontal tests with relative graphs and statistics.
7. The diagnostic system according to claim 6, charac terized in that said personal data comprises a series of algorithmic categories, such as a list of patients, a list of the personal data of each patient, a case his tory, information on the dental situation and documents on tests prescribed and effected and said screening vari able comprises the number of decayed teeth present, the situation relating to periodontitis, halitosis and the temporomandibular joint.
8. The diagnostic system according to claim 2, charac terized in that said algorithms of said software process a series of parameters relating to the various patholo gies of the oral cavity, such as the microbiological situation and the risk of tooth decay, measurement of the salivation, risks of periodontal diseases, the risk of perimplantitis, genetic predispositions, radiographic situation, risk of periodontitis, a combined evaluation of the parameters for a diagnosis indicating the gravity of the single pathologies or pathologies associated with each other.
9. method according to claim 4, characterized in that it comprises a further promotion phase of said soft ware and said diagnostic products, whereby an operator can send the printouts prepared by said software via internet to a service centre, which electronically proc esses the medical reports and sends them back via inter net to the operator.
10. The method according to claim 9, characterized in that it comprises a further training phase of said opera tor, whose cost is included in a prefixed fee, a tele phonic assistance phase and an updating phase of said software.
Description:
INTEGRATED DIAGNOSTIC SYSTEM FOR THE ORAL CAVITY Tooth decay and periodontal disease are widespread conditions which can cause significant destruction to the stomatognatic apparatus, necessitating at times intensive therapy and consequent social costs comparable to those caused by serious illnesses such as coronary disease or AIDS.

The treatment of periodontal diseases and tooth de- cay, however, as also the prostodontic reconstruction of parts of the dental arches, which is often necessary, is often effected in the absence of accurate diagnostic ob- servations ; this leads to frequent short and long term failure.

Furthermore, the application of dental implants is often carried out without a diagnosis of periodontal and/or microbiological suitability, which provides a bet- ter guarantee of therapeutic success.

In short, the causes of tooth decay and periodontal diseases are well known but the existing diagnostic ele- ments are not appropriately organized for allowing an overall vision of diseases relating to the oral cavity; there are single diagnostic methods for evaluating a per- son's cariogenicity or the presence of halitosis or bac- terial strains prevalent in the oral cavity, but there is

no system for guiding the operator, whether it be a den- tist or an oral diagnostic center, in classifying the pa- tient to enable accurate diagnosis, allowing scientific decisions to be made as to which preventive and therapeu- tic options are most appropriate for maintaining or ob- taining the dental and periodontal health of the patient.

The objective of the invention is therefore to indi- cate an integrated diagnostic system for the oral cavity, which overcomes the above drawbacks.

Firstly, this integrated diagnostic system for the oral cavity proposes the rapid identification of the main pathologies of the oral cavity of a patient by means of screening tests.

Among the main objectives of the present invention, we would first of all like to mention the evaluation of the cariological situation and risk of being affected by tooth decay.

Another purpose of the present invention is to set up an integrated diagnostic system for the oral cavity which allows a diagnosis of halitosis to be effected on a patient, revealing the origin.

A further objective of the present invention relates to an integrated diagnostic system for the oral cavity, which allows an evaluation to be made of the periodontal situation of a patient and the risk of being affected by

periodontitis.

Yet another objective of the present invention re- lates to an integrated diagnostic system for the oral cavity, which allows a clinical and instrumental evalua- tion to be made, relating to risks for patients in the field of implant therapy.

Last but not least, the present invention relates to an integrated diagnostic system for the oral cavity which is both simple and rapid to use and which can be effected at relatively low costs, in view of the advantages ob- tained.

These and other objectives are achieved by means of an integrated diagnostic system for the oral cavity, ac- cording to claim 1, to which reference should be made for the sake of brevity.

An applicative program for electronic processors ad- vantageously allows a series of clinical and microbio- logical parameters of the patient to be correlated, by means of appropriate algorithms, and the risk of becoming subject to tooth decay, to be evaluated.

Furthermore, the above system correlates the case history of the patient, the data deriving from an objec- tive examination and, in particular, periodontal examina- tion, data deriving from laboratory tests, such as the genetic test and microbiological tests, and provides a

diagnostic opinion, evaluating the gravity and diffusion of the periodontal disease and the risk to which the pa- tient is exposed for the insertion of osseo-integrated implants.

The same software program also correlates case his- tory and dietetic data with instrumental and objective examinations to identify the presence, gravity, patho- genesis and origin of the halitosis.

Further objectives and advantages of the present in- vention will be more evident from the following descrip- tion which relates to an illustrative and preferred, but non-limiting, embodiment of the integrated diagnostic system for the oral cavity, according to the present in- vention, and from the enclosed figures, wherein : -figures 1-5 represent a series of block schemes re- lating to the main parameters used by the algorithms, which form the basis of the software program used in the integrated diagnostic system for the oral cavity, accord- ing to the present invention.

With reference to the above figures, the procedure according to the invention is obviously based on the fact that a particular type of medical report is required for a certain patient, depending on the gravity of the oral situation of the above patient, which is initially con- firmed by screening the main pathologies of the oral cav-

ity.

The patient may subsequently be subjected to more detailed diagnostic procedures with the relative medical reports.

All the services provided by the integrated diagnos- tic system, according to the invention, are prepared in the form of medical reports together with case sheets.

The general examination and diagnostic in-depth analyses are guided by a software program installed on a dedicated electronic processor.

The operator can also use the software with vocal commands, going through the questions required by rela- tive questionnaires to obtain the necessary medical re- ports; when he has finished, the operator can refer, via internet, to a remote service centre which supplies, in very short times, the complete medical report of each pa- tient.

The software is continuously up-dated; these ad- journments can be simply and rapidly received through the network by all dentists in Italy and abroad.

In particular, this applicative software allows up to 5 interrogation chapters or subjects of the patient to be conducted, which are correlated in many points: per- sonal data, screening, tooth decay, halitosis, periodon- tal situation.

The interrogation relating to personal data has, in turn, five algorithmic categories, such as the list of patients under analysis, the personal data of each single patient, the case history relating to any possible clini- cal problems of the patient, the dental formula suitable for indicating any possible missing teeth, and other documents, such as a summary of the tests prescribed and those effected and a printout with the list of the pre- scriptions of tests to be carried out.

As far as the screening is concerned, this comprises an evaluation of the tooth decay situation, starting from the number of fillings, decayed and missing teeth, of the periodontal situation, for example an evaluation of the mobility, recessions, furcations and periodontal pockets, halitosis, meaning the presence or absence of halitosis, with an organoleptic control test, and the situation re- lating to the temporo-mandibular joint or TMJ.

The decay parameter is subdivided into an additional three interrogation categories and more precisely, case history, specification of the decay problem, food report which examines the patient's diet, laboratory tests, specifications of the tooth decay situation, such as salivary flow, saliva buffer power and lactobacilli and streptococci present, and the decay risk parameter which indicates the probability of not having any further tooth

decay in the future.

The characteristics of halitosis are revealed through the case history (patient's and others'opinion on the intensity of bad breath, food habits, alcohol, to- bacco, hygiene, digestive system, other symptoms), the organoleptic test (halitosis zone, prevalent origin, ex- amination of the tongue, food stagnation and salivation) and halitometry, an instrumental examination which meas- ures the quantity of volatile sulfurated compounds and the prevalent halitosis zone.

The periodontal situation comprises the periodontal case history ; an objective examination guided by data in- sertion per sextant, including the oral and lingual situation of the gums, furcations, recessions, pockets and relative bleeding, any plaque possibly present and mobility; various radiological and laboratory tests, such as the search for any pathogenic germs present or the DNA test for individual susceptibility to periodontitis or other hematological tests.

The software processes various interesting parame- ters which are taken into consideration for the diagno- sis, according to the invention and referring, in par- ticular, to: 1) periodontal graphs, which indicate the situation of the pockets, recessions, bleeding, bacterial plaque, sites with furcations, mobility and number of ad-

herent gum sites ; 2) periodontal statistics, which are capable of graphically representing the percentage subdi- vision of sites with pockets having a depth upon examina- tion of over 4 mm, the number of furcations subdivided into gravity of the defect, gravity of edentulism, the percentage of sites with bleeding upon examination and details of the plaque situation for each single tooth, subdivided by zone.

This enables a detailed and structured diagnosis of the oral cavity to be effected with the help of all pos- sible information, which is continuously up-dated in the applicative program and in the diagnostic products avail- able.

Clinical, laboratory and research experience in the dental and periodontal field has allowed a series of pa- rameters to be selected, which predict, to different ex- tents, the various pathologies which afflict the oral cavity.

In particular, these parameters refer to: dietetic factors and the risk of tooth decay, microbiological situation and risk of tooth decay; quantitative saliva- tion measuring and risk of tooth decay ; determination of saliva pH and risk of tooth decay ; microbiological situa- tion and risk of being affected by periodontal disease; microbiological situation and risk of perimplantitis; ge-

netic predisposition towards periodontopathy ; radio- graphic situation and risk of tooth decay; radiographic situation and risk of being affected by periodontal dis- ease; radiographic situation and risk of perimplantitis ; depth upon examination of the periodontal pockets and the risk of periodontopathy ; bleeding upon examination and the risk of being affected by periodontitis; the presence of tooth decay, periodontitis and particular diets asso- ciated with halitosis.

Finally, account must be taken of a final combined evaluation of the parameters identified in the previous points, in order to arrive at a diagnosis, bearing in mind the gravity of the single pathologies (decay, hali- tosis, periodontitis, implant risk) or a combination of these ; said diagnosis is therefore based on a study of new research and discoveries in world-wide literature and is continually up-dated on the basis of new facts pre- sented.

Furthermore, the present invention proposes a rela- tive sales process of the applicative program used and diagnostic products currently available, allowing the client to simply install the software program on his own electronic processor and subsequently examine the patient in accordance with the interrogations and make any diag- nostic tests held necessary by the software program.

After inserting the answers, the operator can send the printouts indicated by the applicative program via internet to a service centre which electronically proc- esses the medical reports and sends them back to the cli- ent via internet.

In this context, there is also the possibility of training clients by means of formative courses, whose cost is included in a three-monthly subscriber's fee.

Telephone assistance is also available for problems associated with using the software program or the use of the diagnostic products supplied and software up-dating whenever improvements are effected.

The client can also purchase the necessary diagnos- tic products directly from the distributor.

Diagnostic products requiring laboratory procedures which cannot be effected by the client will be sent by the latter to an address indicated, to enable the labora- tory selected to send the results back as soon as possi- ble. The dentist, or one of his assistants, can directly carry out any laboratory tests when allowed by the spe- cific diagnostics.

Finally, a three-monthly fee can be invoiced by the distributor for training, use and periodical up-dating, through the network, of the software program contents.

The invoicing is made for each single medical re-

port, on the basis of a pre-established price-list and, in the case of non-payment, the electronic delivery of the medical report will be interrupted. In the case of prolonged insolvency, the distributor will interrupt all services.

If the non-payment relates only to consultation via internet, in order to obtain medical reports, it will be decided whether or not to continue the supply of diagnos- tic products.

The service users described are trained by the dis- tributor and, after the first pilot period, the initial users will become speakers at training courses destined for new clients.

Assistance for the use of the software program and diagnostics is guaranteed by the distributor, whereas the storage, distribution, invoicing, book-keeping, training and assistance are entrusted to external structures.

The above description clearly describes the charac- teristics of the integrated diagnostic system for the oral cavity, object of the present invention, together with the advantages.

Finally, numerous variations can evidently be ap- plied to the diagnostic system for the oral cavity, ob- ject of the present invention, without excluding any of the novelty principles which characterize the inventive

idea. It is also evident that in the embodiment of the invention, the materials, forms and dimensions of the de- tails illustrated can vary according to the demands and can be substituted with other technically equivalent al- ternatives.