Chemical apparatus and process disinfecting – deodorizing – preser – Analyzer – structured indicator – or manipulative laboratory... – Sample mechanical transport means in or for automated...
Reexamination Certificate
2000-08-21
2001-08-28
Stucker, Jeffrey (Department: 1648)
Chemical apparatus and process disinfecting, deodorizing, preser
Analyzer, structured indicator, or manipulative laboratory...
Sample mechanical transport means in or for automated...
C422S051000, C435S007100, C435S975000, C436S516000, C436S518000, C436S531000, C530S387100, C530S388100, C530S388260, C530S389100, C530S391100, C530S391300
Reexamination Certificate
active
06280687
ABSTRACT:
BACKGROUND OF THE INVENTION
The invention relates to methods and test kits for diagnosis of periodontal disease activity in mammals, especially in human. The methods of the invention provide for rapid chair-side diagnosis of periodontitis, peri-implantitis and HIV (+)-infection/AIDS-disease related periodontal diseases. Especially, the methods of the invention provide for rapid chair-side diagnosis of the loss of bone density associated with periodontal diseases.
Periodontal diseases are a major problem in the human dentition. In fact, more teeth are lost from periodontal disease than from dental caries. Thus, there is a great need for reliable diagnostic tests for periodontal disease.
Periodontal disease comprises a group of inflammatory disorders originating from infections affecting the gingiva (gum), periodontal ligament (a periodontal structural element/tissue linking tooth to alveolar bone) and the alveolar (law) bone structures supporting the teeth. The primary cause of periodontal diseases is bacterial plaque attached to the teeth. This causes inflammation of the gum which may result in destruction of the actual tooth-supporting structure and bone. In periodontal disease, there is usually a large accumulation of bacteria in plaque, both above (supragingival) and below (subgingival) the gum line. The plaque can calcify and form calculus deposits. The calculus deposit and associated plaque can create a “pocket” between the teeth and the gingiva which is an irreversible characteristic of periodontal disease.
Gingivitis (gum inflammation) is distinguished from periodontitis in that in gingivitis, gingiva are inflamed but no deep (>4 mm) periodontal pockets are detectable; thus, no irreversible destruction of tooth supporting structures is associated with gingivitis. Periodontitis is characterized by inflamed gingiva and destruction of tooth supporting structures; however, periodontitis can be missed in clinically-healthy-looking gingiva.
Several methods for detecting periodontal disease have been developed (Armitage, G. C., C.D.A. Journal 36, 35-41, 1993). However, none of the presently available detection methods is sufficiently accurate and specific to provide a reliable tool for diagnosing and assessing the hard tissue destruction associated with periodontal diseases, including peri-implantitis and HIV (+)-infections/AIDS-related periodontal diseases.
Especially, several attempts to develop methods for assessing progressing periodontitis, as discussed below, have been tested but none of them have been found to be satisfactory enough to create a rapid and reliable chair-side test for the hard tissue destruction (bone resorption) associated with periodontal disease.
Visual Examination
When gingiva (gums) are affected by periodontal disease, color change (from pink to red), texture alterations (redness and swelling), and an increased tendency to bleed (in that particular gingival and sulcular/sulcus area) can be detected. Advanced stage periodontal disease is frequently associated with increased tooth mobility and drifting of the teeth.
However, some forms of periodontal disease, such as localized juvenile periodontitis (LJP), can have a treacherous nature and a misleading clinical course. Thus, active local periodontitis is not always detectable by visual examinations. Consequently, biochemical adjunctive means to help the clinical diagnosis of juvenile periodontitis would be desirable and helpful for prompt and adequate early diagnosis, as well as identification and screening, especially in case of young patients.
Clinical Assessment of Periodontal Status and Probing of Periodontal Lesions
Currently, periodontal disease is diagnosed by clinical observation of indicators such as presence and depths of periodontal pockets, loss of attachment of the teeth to the bone, and papillary bleeding of the gums. Clinical observations, however, are not always reliable indicators. For example, even deep periodontitis pockets containing putative periodontal pathogens are not necessarily indicative of disease activity or periodontal tissue destruction.
Periodontal attachment levels can be assessed by means of a graduated periodontal probe and expressed as the distance from the cement enamel junction to the bottom of the gingival pocket. The longer distance for each tooth surface is recorded and may be included in the periodontium chart. Pocket depth values <4 mm are excluded from the chart as falling within normal variations. Thus, pockets >4 mm are considered as periodontitis pockets or periodontitis lesions.
As a measurement technique, periodontal probing has several sources of error. The extent of probe penetration varies with insertion force, inflammatory status of the periodontal tissues, and diameter of probe tip. Measurement errors resulting from thickness of the probe, contour of the tooth surface and improper angulation of the probe can be reduced or avoided by the selection of a proper instrument and careful management of the examination procedure. More difficult to avoid, however, are errors resulting from variations in probing force and inflammation of the periodontal tissues. The measurement errors limit the accuracy and reproducibility.
Automated periodontal probes have also been developed. The primary advantage is controlled insertion force, reproducibility, and direct data entry. The main disadvantages include reduced tactile sense of operator and patient discomfort.
Noteworthy, gingivitis or gum inflammation is distinguished from periodontitis by the facts that in gingivitis, unlike periodontitis, gingiva is inflamed but no deep (>4 mm) periodontal pockets can be detected; thus, no irreversible degradation (destruction) of tooth supporting structures either detected by probing and/or radiographically is associated with gingivitis. Periodontitis is characterized by inflamed gingiva and destruction of tooth supporting structures; however, periodontitis can well exist under “clinically-healthy-looking” gingiva.
In conclusion, it is clear that clinical observations are not always reliable indicators. A further problem is the difficulty to assess an progressing periodontal disease because in some cases deep periodontitis pockets—even harboring putative periodontopathogens—are not necessarily active in regard to the inflammatory periodontal tissue destruction.
Radiographic Evaluation
Sequential radiographic images have also been used to evaluate periodontal disease activity. The loss of bone density at the alveolar crest is frequently a sign of progression of periodontitis.
The height of the alveolar (jaw) bone and the outline of the bone crest can be examined in the radiographs. The radiographs provide information of the height and configuration of the interproximal alveolar bone. However, the radiographic assessment of the periodontal disease activity has drawbacks. Even with an excellent set of films and an experienced examiner, the unaided eye can only detect changes in bone after 30-50 percent of the bone mineral has been lost. Cover structures (bone, tissue, teeth) often make it difficult to properly identify the outlines of buccal and lingual alveolar crests. The analysis of radiographs is to be combined with a detailed evaluation of the pocket depths and the attachment level data to obtain a correct and exact diagnosis. Upon recalls (examinations of treated periodontitis patients) radiographic examination is required.
In summary, periodontal probes and radiographs measure two separate components in the progression of periodontitis. One provides an estimate of the attachment loss of soft tissue from the tooth surface and the other measures loss of bone density.
Biological Tests
In addition to periodontal probing, biological (microbial and biochemical) tests have been designed to provide information associated with progressing periodontal lesions. These biological periodontitis tests fall into four general categories and are designed to detect the presence of 1) substances associated with putative pathogens, 2) tissue breakdown products, 3) proinf
Golub Lorne M.
Sorsa Timo
Teronen Olli
Tikanoja Sari Hannele
Hoffmann & Baron , LLP
Stucker Jeffrey
The Research Foundation of State University of NY
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