Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576856
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Salivary Markers in Periodontal Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Salivary Markers to Heralding the Onset of Periodontal Disorders
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The swelling of the gum or periodontitis is the leading cause for tooth loss and currently affects up to 65 million adults only in the United States One of the reasons for the widespread of periodontitis is because currently there are no definitive methods to detect the onset of gum disease This lack of foresight impedes medical professionals to enact any preventive measures before the disease already manifests itself
We wish to expand our understanding towards the development of periodontitis by studying the expression and activity of salivary markers that have been associated with advanced stages of the disease wherein the supporting tissues of tooth periodontium are already irreversibly destroyed We hypothesize that a progressive shift in the expression of such salivary markers can indicate a change or evolution of periodontitis staging
In specific we seek to establish a quantifiable relationship among levels of salivary proteases called MMPs level of metal ions in different stages varying from health to periodontitis The overall goal of this proposal is to enhance the predictability of periodontitis as we are currently unable to diagnose the disease until the manifestation of its clinical signs and symptoms
We wish to expand our understanding towards the development of periodontitis by studying the expression and activity of salivary markers that have been associated with advanced stages of the disease wherein the supporting tissues of tooth periodontium are already irreversibly destroyed We hypothesize that a progressive shift in the expression of such salivary markers can indicate a change or evolution of periodontitis staging
In specific we seek to establish a quantifiable relationship among levels of salivary proteases called MMPs level of metal ions in different stages varying from health to periodontitis The overall goal of this proposal is to enhance the predictability of periodontitis as we are currently unable to diagnose the disease until the manifestation of its clinical signs and symptoms
Detailed Description:
There is an urgent need for an efficient system to diagnose periodontal disease in its early stages A recent investigation on the prevalence of periodontitis in adults living in the USA revealed that almost 50 of the assayed individuals had periodontal disease 1 Research on the economic burden of oral diseases estimated that productivity losses due to severe periodontitis and consequently due to tooth loss in North America US and Canada amounted US 116 billion yearly 2 This pervasiveness of periodontitis can be attributed to the conventional method of diagnosis which is entirely based upon recognizing observable signs - an assessment of the diseases history
A crucial restraint of these observable parameters is that they do not detect present disease activity 3 and therefore cannot provide a real-time evaluation of the disease status 45 The lack of evidence-based knowledge regarding periodontal diseases activity and level of progression may ultimately lead to unintentional clinical mismanagement 6 Accordingly there is an unmet requisite for easy and readily available methods to herald the periodontium health condition prior to the manifestation of disease clinical signs 7
Periodontal diseases are identified as being resultant from an inflammatory host-mediated response associated with dysbiotic plaque biofilms 89 Within the inflammatory host response of periodontal diseases there is a group of enzymes that are key the matrix metalloproteinases MMP10 The abundance of MMPs more specifically MMP-8 in saliva of individuals with severe periodontitis has shown to be high 1112 In physiological conditions the activity of MMPs is tightly controlled by changes in the balance between their expression and the expression of their major tissue endogenous inhibitors called TIMPs 10 In addition the catalytic competence of MMPs is highly dependent on the concentration of specific metal ions zinc and calcium which justifies the use of the prefix metal to classify and group this proteinase superfamily As MMP-inhibitory medication has been shown to reduce the levels of MMPs in oral fluids 1113 we hypothesize that collection of oral fluid samples ie saliva andor gingival crevicular fluid from individuals appertaining to different stages of periodontal diseases can identify a shift in the balance between MMPs and their tissue-regulatory factors
The overall objective of this proposal is to contribute to enhance the predictability of periodontitis and identify a method to heralding its onset We hypothesize that the levels of salivary MMPs and other factors modulating these enzymes activity relate with different clinical stages of periodontal disease The questions this research will address are Do the level of MMPs vary as a function of periodontium health state Is there a quantifiable relationship between salivary MMPs and other markers such as MMP-Tissue Inhibitors TIMPs and metal ions in the context of periodontitis
Thus the specific aims of this purposed study are
To measure the levels of MMPs and MMPs tissue-regulatory factors TIMPs and metal ions in oral fluids of adults displaying different clinical status of periodontium integrity from health stage 0 to severe periodontitis stage IV
To determine the relationship of periodontitis clinical staging and levels of salivary MMPs and MMPs regulatory factors
Cited Literature
1 Eke PI Dye BA Wei L et al Prevalence of periodontitis in adults in the United States 2009 and 2010 J Dent Res 2012 91 914-920
2 Listl S Galloway J Mossey PA et al Global Economic Impact of Dental Diseases J Dent Res 2015 94 1355-1361
3 Ji S Choi Y Point-of-care diagnosis of periodontitis using saliva technically feasible but still a challenge Front Cell Infect Microbiol 565 2015 doi 103389fcimb201500065
4 Lang NP Tonetti MS Periodontal diagnosis in treated periodontitis Why when and how to use clinical parameters J Clin Periodontol 1996 23 240-250
5 Kwok V Caton JG Polson AM et al Application of evidence based dentistry From research to clinical periodontal practice Periodontol 2000 2012 59 61-74
6 Slots J Periodontology Past present perspectives Periodontol 2000 2013 62 7-19
7 Giannobile WV Beikler T Kinney JS et al Saliva as a diagnostic tool for periodontal disease Current state and future directions Periodontol 2000 2009 5052-64
8 Papapanou PN Sanz M Buduneli N et al Periodontitis Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions J Periodontol 2018 89Suppl 1 S173-S182
9 Schwarz F Derks J Monje A et al Peri-implantitis J Periodontol 89Suppl 1 S267-S290 2018
10 Sorsa T Tjäderhane L Salo T Matrix metalloproteinases MMPs in oral diseases Oral Dis 2004 10 311-318
11 Sorsa T Gursoy UK Nwhator S et al Analysis of matrix metalloproteinases especially MMP-8 in gingival crevicular fluid mouthrinse and saliva for monitoring periodontal diseases Periodontol 2000 70 142-163 2016
12 de Morais EF Pinheiro JC Leite RB et al Matrix metalloproteinase-8 levels in periodontal disease patients A systematic review J Periodontal Res 2018 53156-163
13 Butler GS Overall CM Matrix metalloproteinase processing of signaling molecules to regulate inflammation Periodontol 2000 2013 63 123-148
A crucial restraint of these observable parameters is that they do not detect present disease activity 3 and therefore cannot provide a real-time evaluation of the disease status 45 The lack of evidence-based knowledge regarding periodontal diseases activity and level of progression may ultimately lead to unintentional clinical mismanagement 6 Accordingly there is an unmet requisite for easy and readily available methods to herald the periodontium health condition prior to the manifestation of disease clinical signs 7
Periodontal diseases are identified as being resultant from an inflammatory host-mediated response associated with dysbiotic plaque biofilms 89 Within the inflammatory host response of periodontal diseases there is a group of enzymes that are key the matrix metalloproteinases MMP10 The abundance of MMPs more specifically MMP-8 in saliva of individuals with severe periodontitis has shown to be high 1112 In physiological conditions the activity of MMPs is tightly controlled by changes in the balance between their expression and the expression of their major tissue endogenous inhibitors called TIMPs 10 In addition the catalytic competence of MMPs is highly dependent on the concentration of specific metal ions zinc and calcium which justifies the use of the prefix metal to classify and group this proteinase superfamily As MMP-inhibitory medication has been shown to reduce the levels of MMPs in oral fluids 1113 we hypothesize that collection of oral fluid samples ie saliva andor gingival crevicular fluid from individuals appertaining to different stages of periodontal diseases can identify a shift in the balance between MMPs and their tissue-regulatory factors
The overall objective of this proposal is to contribute to enhance the predictability of periodontitis and identify a method to heralding its onset We hypothesize that the levels of salivary MMPs and other factors modulating these enzymes activity relate with different clinical stages of periodontal disease The questions this research will address are Do the level of MMPs vary as a function of periodontium health state Is there a quantifiable relationship between salivary MMPs and other markers such as MMP-Tissue Inhibitors TIMPs and metal ions in the context of periodontitis
Thus the specific aims of this purposed study are
To measure the levels of MMPs and MMPs tissue-regulatory factors TIMPs and metal ions in oral fluids of adults displaying different clinical status of periodontium integrity from health stage 0 to severe periodontitis stage IV
To determine the relationship of periodontitis clinical staging and levels of salivary MMPs and MMPs regulatory factors
Cited Literature
1 Eke PI Dye BA Wei L et al Prevalence of periodontitis in adults in the United States 2009 and 2010 J Dent Res 2012 91 914-920
2 Listl S Galloway J Mossey PA et al Global Economic Impact of Dental Diseases J Dent Res 2015 94 1355-1361
3 Ji S Choi Y Point-of-care diagnosis of periodontitis using saliva technically feasible but still a challenge Front Cell Infect Microbiol 565 2015 doi 103389fcimb201500065
4 Lang NP Tonetti MS Periodontal diagnosis in treated periodontitis Why when and how to use clinical parameters J Clin Periodontol 1996 23 240-250
5 Kwok V Caton JG Polson AM et al Application of evidence based dentistry From research to clinical periodontal practice Periodontol 2000 2012 59 61-74
6 Slots J Periodontology Past present perspectives Periodontol 2000 2013 62 7-19
7 Giannobile WV Beikler T Kinney JS et al Saliva as a diagnostic tool for periodontal disease Current state and future directions Periodontol 2000 2009 5052-64
8 Papapanou PN Sanz M Buduneli N et al Periodontitis Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions J Periodontol 2018 89Suppl 1 S173-S182
9 Schwarz F Derks J Monje A et al Peri-implantitis J Periodontol 89Suppl 1 S267-S290 2018
10 Sorsa T Tjäderhane L Salo T Matrix metalloproteinases MMPs in oral diseases Oral Dis 2004 10 311-318
11 Sorsa T Gursoy UK Nwhator S et al Analysis of matrix metalloproteinases especially MMP-8 in gingival crevicular fluid mouthrinse and saliva for monitoring periodontal diseases Periodontol 2000 70 142-163 2016
12 de Morais EF Pinheiro JC Leite RB et al Matrix metalloproteinase-8 levels in periodontal disease patients A systematic review J Periodontal Res 2018 53156-163
13 Butler GS Overall CM Matrix metalloproteinase processing of signaling molecules to regulate inflammation Periodontol 2000 2013 63 123-148
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None